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1.  Plantar Pressure as a Risk Assessment Tool for Diabetic Foot Ulceration in Egyptian Patients with Diabetes 
BACKGROUND
Diabetic foot ulceration is a preventable long-term complication of diabetes. In the present study, peak plantar pressures (PPP) and other characteristics were assessed in a group of 100 Egyptian patients with diabetes with or without neuropathy and foot ulcers. The aim was to study the relationship between plantar pressure (PP) and neuropathy with or without ulceration and trying to clarify the utility of pedobarography as an ulceration risk assessment tool in patients with diabetes.
SUBJECTS AND METHODS
A total of 100 patients having diabetes were selected. All patients had a comprehensive foot evaluation, including assessment for neuropathy using modified neuropathy disability score (MNDS), for peripheral vascular disease using ankle brachial index, and for dynamic foot pressures using the MAT system (Tekscan). The studied patients were grouped into: (1) diabetic control group (DC), which included 37 patients who had diabetes without neuropathy or ulceration and MNDS ≤2; (2) diabetic neuropathy group (DN), which included 33 patients who had diabetes with neuropathy and MNDS >2, without current or a history of ulceration; and (3) diabetic ulcer group (DU), which included 30 patients who had diabetes and current ulceration, seven of those patients also gave a history of ulceration.
RESULTS
PP parameters were significantly different between the studied groups, namely, forefoot peak plantar pressure (FFPPP), rearfoot peak plantar pressure (RFPPP), forefoot/rearfoot ratio (F/R), forefoot peak pressure gradient (FFPPG) rearfoot peak pressure gradient (RFPPG), and forefoot peak pressure gradient/rearfoot peak pressure gradient (FFPPG/RFPPG) (P < 0.05). FFPPP and F/R were significantly higher in the DU group compared to the DN and DC groups (P < 0.05), with no significant difference between DN and DC. FFPPG was significantly higher in the DU and DN groups compared to the DC group (P < 0.05). RFPPP and FFPPG/RFPPG were significantly higher in the DU and DN groups compared to the DC group (P < 0.05) with no significant difference between the DN and DU groups (P > 0.05). FFPPP, F/R ratio, FFPPG, and FFPPG/RFPPG correlated significantly with the severity of neuropathy according to MNDS (P < 0.05). These same variables as well as MNDS were also significantly higher in patients with foot deformity compared to those without deformity (P < 0.05). Using the receiver operating characteristic analysis, the optimal cut-point of PPP for ulceration risk, as determined by a balance of sensitivity, specificity, and accuracy was 335 kPa and was found at the forefoot. Multivariate logistical regression analysis for ulceration risk was statistically significant for duration of diabetes (odds ratio [OR] = 0.8), smoking (OR = 9.7), foot deformity (OR = 8.7), MNDS (OR = 1.5), 2-h postprandial plasma glucose (2 h-PPG) (OR = 0.9), glycated hemoglobin (HbA1c) (OR = 2.1), FFPPP (OR = 1.0), and FFPPG (OR = 1.0).
CONCLUSION
In conclusion, persons with diabetes having neuropathy and/or ulcers have elevated PPP. Risk of ulceration was highly associated with duration of diabetes, smoking, severity of neuropathy, glycemic control, and high PP variables especially the FFPPP, F/R, and FFPPG. We suggest a cut-point of 355 kPa for FFPPP to denote high risk for ulceration that would be more valid when used in conjunction with other contributory risk factors, namely, duration of diabetes, smoking, glycemic load, foot deformity, and severity of neuropathy.
doi:10.4137/CMED.S17088
PMCID: PMC4257475  PMID: 25520564
pedobarography; plantar pressure; diabetic neuropathy; diabetic foot ulceration
2.  Community-Based Care for Chronic Wound Management 
Executive Summary
In August 2008, the Medical Advisory Secretariat (MAS) presented a vignette to the Ontario Health Technology Advisory Committee (OHTAC) on a proposed targeted health care delivery model for chronic care. The proposed model was defined as multidisciplinary, ambulatory, community-based care that bridged the gap between primary and tertiary care, and was intended for individuals with a chronic disease who were at risk of a hospital admission or emergency department visit. The goals of this care model were thought to include: the prevention of emergency department visits, a reduction in hospital admissions and re-admissions, facilitation of earlier hospital discharge, a reduction or delay in long-term care admissions, and an improvement in mortality and other disease-specific patient outcomes.
OHTAC approved the development of an evidence-based assessment to determine the effectiveness of specialized community based care for the management of heart failure, Type 2 diabetes and chronic wounds.
Please visit the Medical Advisory Secretariat Web site at: www.health.gov.on.ca/ohtas to review the following reports associated with the Specialized Multidisciplinary Community-Based care series.
Specialized multidisciplinary community-based care series: a summary of evidence-based analyses
Community-based care for the specialized management of heart failure: an evidence-based analysis
Community-based care for chronic wound management: an evidence-based analysis
Please note that the evidence-based analysis of specialized community-based care for the management of diabetes titled: “Community-based care for the management of type 2 diabetes: an evidence-based analysis” has been published as part of the Diabetes Strategy Evidence Platform at this URL: http://www.health.gov.on.ca/english/providers/program/mas/tech/ohtas/tech_diabetes_20091020.html
Please visit the Toronto Health Economics and Technology Assessment Collaborative Web site at: http://theta.utoronto.ca/papers/MAS_CHF_Clinics_Report.pdf to review the following economic project associated with this series:
Community-based Care for the specialized management of heart failure: a cost-effectiveness and budget impact analysis.
Objective
The objective of this evidence-based review is to determine the effectiveness of a multidisciplinary wound care team for the management of chronic wounds.
Clinical Need: Condition and Target Population
Chronic wounds develop from various aetiologies including pressure, diabetes, venous pathology, and surgery. A pressure ulcer is defined as a localized injury to the skin/and or underlying tissue occurring most often over a bony prominence and caused, alone or in combination, by pressure, shear, or friction. Up to three fifths of venous leg ulcers are due to venous aetiology.
Approximately 1.5 million Ontarians will sustain a pressure ulcer, 111,000 will develop a diabetic foot ulcer, and between 80,000 and 130,000 will develop a venous leg ulcer. Up to 65% of those afflicted by chronic leg ulcers report experiencing decreased quality of life, restricted mobility, anxiety, depression, and/or severe or continuous pain.
Multidisciplinary Wound Care Teams
The term ‘multidisciplinary’ refers to multiple disciplines on a team and ‘interdisciplinary’ to such a team functioning in a coordinated and collaborative manner. There is general consensus that a group of multidisciplinary professionals is necessary for optimum specialist management of chronic wounds stemming from all aetiologies. However, there is little evidence to guide the decision of which professionals might be needed form an optimal wound care team.
Evidence-Based Analysis Methods
Literature Search
A literature search was performed on July 7, 2009 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, Wiley Cochrane, Centre for Reviews and Dissemination/International Agency for Health Technology Assessment, and on July 13, 2009 using the Cumulative Index to Nursing & Allied Health Literature (CINAHL), and the International Agency for Health Technology Assessment (INAHTA) for studies pertaining to leg and foot ulcers. A similar literature search was conducted on July 29’ 2009 for studies pertaining to pressure ulcers. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with an unknown eligibility were reviewed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established.
Inclusion Criteria
Randomized controlled trials and Controlled clinical Trials (CCT)
Systematic review with meta analysis
Population includes persons with pressure ulcers (anywhere) and/or leg and foot ulcers
The intervention includes a multidisciplinary (two or more disciplines) wound care team.
The control group does not receive care by a wound care team
Studies published in the English language between 2004 and 2009
Exclusion Criteria
Single centre retrospective observational studies
Outcomes of Interest
Proportion of persons and/or wounds completely healed
Time to complete healing
Quality of Life
Pain assessment
Summary of Findings
Two studies met the inclusion and exclusion criteria, one a randomized controlled trial (RCT), the other a CCT using a before and after study design. There was variation in the setting, composition of the wound care team, outcome measures, and follow up periods between the studies. In both studies, however, the wound care team members received training in wound care management and followed a wound care management protocol.
In the RCT, Vu et al. reported a non-significant difference between the proportion of wounds healed in 6 months using a univariate analysis (61.7% for treatment vs. 52.5% for control; p=0.074, RR=1.19) There was also a non-significant difference in the mean time to healing in days (82 for treatment vs. 101 for control; p=0.095). More persons in the intervention group had a Brief Pain Inventory (BPI) score equal to zero (better pain control) at 6 months when compared with the control group (38.6% for intervention vs. 24.4% for control; p=0.017, RR=1.58). By multivariate analysis a statistically significant hazard ratio was reported in the intervention group (1.73, 95% CI 1.20-1.50; p=0.003).
In the CCT, Harrison et al. reported a statistically significant difference in healing rates between the pre (control) and post (intervention) phases of the study. Of patients in the pre phase, 23% had healed ulcers 3 months after study enrolment, whereas 56% were healed in the post phase (P<0.001, OR=4.17) (Figure 3). Furthermore, 27% of patients were treated daily or more often in the pre phase whereas only 6% were treated at this frequency in the post phase (P<0.001), equal to a 34% relative risk reduction in frequency of daily treatments. The authors did not report the results of pain relief assessment.
The body of evidence was assessed using the GRADE methodology for 4 outcomes: proportion of wounds healed, proportion of persons with healed wounds, wound associated pain relief, and proportion of persons needing daily wound treatments. In general, the evidence was found to be low to very low quality.
Conclusion
The evidence supports that managing chronic wounds with a multidisciplinary wound care team significantly increases wound healing and reduces the severity of wound-associated pain and the required daily wound treatments compared to persons not managed by a wound care team. The quality of evidence supporting these outcomes is low to very low meaning that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
PMCID: PMC3377537  PMID: 23074522
3.  Diabetic foot: prevalence, knowledge, and foot self-care practices among diabetic patients in Dar es Salaam, Tanzania – a cross-sectional study 
Background
At the time of diagnosis, more than 10 % of people with type 2 diabetes mellitus have one or two risk factors for a foot ulceration and a lifetime risk of 15 %. Diabetic foot ulcers can be prevented through well-coordinated foot care services. The objective of this study was to determine knowledge of foot care and reported practice of foot self-care among diabetic patients with the aim of identifying and addressing barriers to preventing amputations among diabetic patients.
Methods
Patients were randomly selected from all public diabetic clinics in Dar es Salaam. A questionnaire containing knowledge and foot care practice questions was administered to all study participants. A detailed foot examination was performed on all patients, with the results categorized according to the International Diabetes Federation foot risk categories. Statistics were performed using SPSS version 14.
Results
Of 404 patients included in this study, 15 % had foot ulcers, 44 % had peripheral neuropathy, and 15 % had peripheral vascular disease. In multivariate analysis, peripheral neuropathy and insulin treatment were significantly associated with presence of foot ulcer. The mean knowledge score was 11.2 ± 6.4 out of a total possible score of 23. Low mean scores were associated with lack of formal education (8.3 ± 6.1), diabetes duration of < 5 years (10.2 ± 6.7) and not receiving advice on foot care (8.0 ± 6.1). Among the 404 patients, 48 % had received advice on foot care, and 27.5 % had their feet examined by a doctor at least once since their initial diagnosis. Foot self-care was significantly higher in patients who had received advice on foot care and in those whose feet had been examined by a doctor at least once.
Conclusions
The prevalence of diabetic foot is high among patients attending public clinics in Dar es Salaam. There is an urgent need to establish coordinated foot care services within the diabetic clinic to identify feet at risk, institute early management, and provide continuous foot care education to patients and health care providers.
doi:10.1186/s13047-015-0080-y
PMCID: PMC4462176  PMID: 26064190
Diabetes; Diabetic foot; Foot care
4.  Hyperbaric Oxygen Therapy for Non-Healing Ulcers in Diabetes Mellitus 
Executive Summary
Objective
To examine the effectiveness and cost-effectiveness of hyperbaric oxygen therapy (HBOT) to treat people with diabetes mellitus (DM) and non-healing ulcers. This policy appraisal systematically reviews the published literature in the above patient population, and applies the results and conclusions of the review to current health care practices in Ontario, Canada.
Although HBOT is an insured service in Ontario, the costs for the technical provision of this technology are not covered publicly outside the hospital setting. Moreover, access to this treatment is limited, because many hospitals do not offer it, or are not expanding capacity to meet the demand.
Clinical Need
Diabetes mellitus is a chronic disease characterized by an increase in blood sugar that can lead to many severe conditions such as vision, cardiac, and vascular disorders. The prevalence of DM is difficult to estimate, because some people who have the condition are undiagnosed or may not be captured through data that reflect access to the health care system. The Canadian Diabetic Association estimates there are about 2 million people in Canada with diabetes (almost 7% of the population). According to recent data, the prevalence of DM increased from 4.72% of the population aged 20 years and over in 1995, to 6.19% of the population aged 20 years and over in 1999, or about 680,900 people in 1999. Prevalence estimates expanded to 700,000 in 2003.
About 10% to 15% of people with DM develop a foot wound in their lifetimes because of underlying peripheral neuropathy and peripheral vascular disease. This equals between 70,000 and 105,000 people in Ontario, based on the DM prevalence estimate of 700,000 people. Without early treatment, a foot ulcer may fester until it becomes infected and chronic. Chronic wounds are difficult to heal, despite medical and nursing care, and may lead to impaired quality of life and functioning, amputation, or even death.
The Technology
Hyperbaric oxygen therapy has been in use for about 40 years. It is thought to aid wound healing by supplying oxygen to the wound. According to the Hyperbaric Oxygen Therapy Association, HBOT acts as a bactericidal, stops toxin production, and promotes tissue growth to heal difficult wounds.
During the procedure, a patient is placed in a compression chamber with increased pressure between 2.0 and 2.5 atmospheres absolute for 60 to 120 minutes, once or twice daily. In the chamber, the patient inhales 100% oxygen. Treatment usually runs for 15 to 20 sessions.
Noted complications are rare but may include claustrophobia; ear, sinus, or lung damage due to pressure; temporary worsening of short sightedness; and oxygen poisoning. Careful monitoring during the treatment sessions and follow-up by a trained health care provider is recommended.
Review Strategy
The aims of this health technology policy appraisal were to assess the effectiveness, safety, and cost-effectiveness of HBOT, either alone, or as an adjunct, compared with the standard treatments for non-healing foot or leg ulcers in patients with DM. The following questions were asked:
Alone or as an adjunct therapy, is HBOT more effective than other therapies for non-healing foot or leg ulcers in patients with DM?
If HBOT is effective, what is the incremental benefit over and above currently used strategies?
When is the best time in a wound treatment strategy to use HBOT?
What is the best treatment algorithm with HBOT?
The Medical Advisory Secretariat searched for health technology assessments in the published and grey literature. The search yielded 4 reports, which were published from 2000 to 2005. The most recent from the Cochrane Collaboration had a literature review and analysis of randomized control trials to 2003.
As an update to this review, as per the standard Medical Advisory Secretariat systematic review strategy, the abstracts of peer-reviewed publications were identified using Ovid MEDLINE, EMBASE, MEDLINE in-process and not-yet-indexed citations, Cochrane Database of Systematic Reviews, Cochrane CENTRAL, and INAHTA using key words and searching from January 1, 2003 to 2004.
The criteria for inclusion were as follows:
Patients with diabetes
Live human study
English-language study
HBOT as adjunctive therapy or alone
Randomized control trial
The number of excluded studies included the following:
2 animal studies
13 focus on condition other than DM
8 review/protocol for HBOT use
3 HBOT not focus of report
2 health technology assessments (2)
1 non-RCT
Outcomes of interest were wound healing and prevention of amputation.
The search yielded 29 articles published between 2003 and 2004. All 29 of these were excluded, as shown beside the exclusion criteria above. Therefore, this health technology policy assessment focused exclusively on the most recently published health technology assessments and systematic reviews.
Summary of Findings
Four health technology assessments and reviews were found. Cochrane Collaboration researchers published the most recent review in 2005. They included only randomized controlled trials and conducted a meta-analysis to examine wound healing and amputation outcomes. They found that, based on findings from 118 patients in 3 studies, HBOT may help to prevent major amputation (relative risk, 0.31; 95% confidence interval [CI], 0.13–0.71) with a number needed to treat (NNT) of 4 (95% CI, 3–11). They noted, however, that the point estimates derived from trials were not well reported, and had varying populations with respect to wound severity, HBOT regimens, and outcome measures. These noted limitations rendered the comparison of results from the trials difficult. Further, they suggested that the evidence was not strong enough to suggest a benefit for wound healing in general or for prevention of minor amputations.
The Medical Advisory Secretariat also evaluated the studies that the Cochrane Collaboration used in their analysis, and agreed with their evaluation that the quality of the evidence was low for major and minor amputations, but low to moderate for wound healing, suggesting that the results from new and well-conducted studies would likely change the estimates calculated by Cochrane and others.
Conclusions
In 2003, the Ontario Health Technology Advisory Committee recommended a more coordinated strategy for wound care in Ontario to the Ministry of Health and Long-term Care. This strategy has begun at the community care and long-term care institution levels, but is pending in other areas of the health care system.
There are about 700,000 people in Ontario with diabetes; of these, 10% to 15% may have a foot ulcer sometime in their lifetimes. Foot ulcers are treatable, however, when they are identified, diagnosed and treated early according to best practice guidelines. Routine follow-up for people with diabetes who may be at risk for neuropathy and/or peripheral vascular disease may prevent subsequent foot ulcers. There are 4 chambers that provide HBOT in Ontario. Fewer than 20 people with DM received HBOT in 2003.
The quality of the evidence assessing the effectiveness of HBOT as an adjunct to standard therapy for people with non-healing diabetic foot ulcers is low, and the results are inconsistent. The results of a recent meta-analysis that found benefit of HBOT to prevent amputation are therefore uncertain. Future well-conducted studies may change the currently published estimates of effectiveness for wound healing and prevention of amputation using HBOT in the treatment of non-healing diabetic foot ulcers.
Although HBOT is an insured service in Ontario, a well conducted, randomized controlled trial that has wound healing and amputation as the primary end-points is needed before this technology is used widely among patients with foot wounds due to diabetes.
PMCID: PMC3382405  PMID: 23074462
5.  Plantar Pressure in Diabetic Peripheral Neuropathy Patients with Active Foot Ulceration, Previous Ulceration and No History of Ulceration: A Meta-Analysis of Observational Studies 
PLoS ONE  2014;9(6):e99050.
Aims
Elevated dynamic plantar pressures are a consistent finding in diabetes patients with peripheral neuropathy with implications for plantar foot ulceration. This meta-analysis aimed to compare the plantar pressures of diabetes patients that had peripheral neuropathy and those with neuropathy with active or previous foot ulcers.
Methods
Published articles were identified from Medline via OVID, CINAHL, SCOPUS, INFORMIT, Cochrane Central EMBASE via OVID and Web of Science via ISI Web of Knowledge bibliographic databases. Observational studies reporting barefoot dynamic plantar pressure in adults with diabetic peripheral neuropathy, where at least one group had a history of plantar foot ulcers were included. Interventional studies, shod plantar pressure studies and studies not published in English were excluded. Overall mean peak plantar pressure (MPP) and pressure time integral (PTI) were primary outcomes. The six secondary outcomes were MPP and PTI at the rear foot, mid foot and fore foot. The protocol of the meta-analysis was published with PROPSERO, (registration number CRD42013004310).
Results
Eight observational studies were included. Overall MPP and PTI were greater in diabetic peripheral neuropathy patients with foot ulceration compared to those without ulceration (standardised mean difference 0.551, 95% CI 0.290–0.811, p<0.001; and 0.762, 95% CI 0.303–1.221, p = 0.001, respectively). Sub-group analyses demonstrated no significant difference in MPP for those with neuropathy with active ulceration compared to those without ulcers. A significant difference in MPP was found for those with neuropathy with a past history of ulceration compared to those without ulcers; (0.467, 95% CI 0.181– 0.753, p = 0.001). Statistical heterogeneity between studies was moderate.
Conclusions
Plantar pressures appear to be significantly higher in patients with diabetic peripheral neuropathy with a history of foot ulceration compared to those with diabetic neuropathy without a history of ulceration. More homogenous data is needed to confirm these findings.
doi:10.1371/journal.pone.0099050
PMCID: PMC4051689  PMID: 24915443
6.  Depression and incident diabetic foot ulcers: a prospective cohort study 
The American journal of medicine  2010;123(8):748-754.e3.
Objective
To test whether depression is associated with an increased risk of incident diabetic foot ulcers.
Methods
The Pathways Epidemiologic Study is a population-based prospective cohort study of 4839 patients with diabetes in 2000–2007. The present analysis included 3474 adults with type 2 diabetes and no prior diabetic foot ulcers or amputations. Mean follow-up was 4.1 years. Major and minor depression assessed by the Patient Health Questionnaire-9 (PHQ-9) were the exposures of interest. The outcome of interest was incident diabetic foot ulcers. We computed the hazard ratio (HR) and 95% CI for incident diabetic foot ulcers, comparing patients with major and minor depression to those without depression and adjusting for sociodemographic characteristics, medical comorbidity, glycosylated hemoglobin (HbA1c), diabetes duration, insulin use, number of diabetes complications, body mass index, smoking status, and foot self-care. Sensitivity analyses also adjusted for peripheral neuropathy and peripheral arterial disease as defined by diagnosis codes.
Results
Compared to patients without depression, patients with major depression by PHQ-9 had a two-fold increase in the risk of incident diabetic foot ulcers (adjusted HR 2.00, 95% CI: 1.24, 3.25). There was no statistically significant association between minor depression by PHQ-9 and incident diabetic foot ulcers (adjusted HR 1.37, 95% CI: 0.77, 2.44).
Conclusion
Major depression by PHQ-9 is associated with a two-fold higher risk of incident diabetic foot ulcers. Future studies of this association should include better measures of peripheral neuropathy and peripheral arterial disease, which are possible confounders and/or mediators.
doi:10.1016/j.amjmed.2010.01.023
PMCID: PMC2913143  PMID: 20670730
diabetes; depression; foot ulcers; complications
7.  Lower limb biomechanical characteristics of patients with neuropathic diabetic foot ulcers: the diabetes foot ulcer study protocol 
Background
Foot ulceration is the main precursor to lower limb amputation in patients with type 2 diabetes worldwide. Biomechanical factors have been implicated in the development of foot ulceration; however the association of these factors to ulcer healing remains less clear. It may be hypothesised that abnormalities in temporal spatial parameters (stride to stride measurements), kinematics (joint movements), kinetics (forces on the lower limb) and plantar pressures (pressure placed on the foot during walking) contribute to foot ulcer healing. The primary aim of this study is to establish the biomechanical characteristics (temporal spatial parameters, kinematics, kinetics and plantar pressures) of patients with plantar neuropathic foot ulcers compared to controls without a history of foot ulcers. The secondary aim is to assess the same biomechanical characteristics in patients with foot ulcers and controls over-time to assess whether these characteristics remain the same or change throughout ulcer healing.
Methods/Design
The design is a case–control study nested in a six-month longitudinal study. Cases will be participants with active plantar neuropathic foot ulcers (DFU group). Controls will consist of patients with type 2 diabetes (DMC group) and healthy participants (HC group) with no history of foot ulceration. Standardised gait and plantar pressure protocols will be used to collect biomechanical data at baseline, three and six months. Descriptive variables and primary and secondary outcome variables will be compared between the three groups at baseline and follow-up.
Discussion
It is anticipated that the findings from this longitudinal study will provide important information regarding the biomechanical characteristic of type 2 diabetes patients with neuropathic foot ulcers. We hypothesise that people with foot ulcers will demonstrate a significantly compromised gait pattern (reduced temporal spatial parameters, kinematics and kinetics) at base line and then throughout the follow-up period compared to controls. The study may provide evidence for the design of gait-retraining, neuro-muscular conditioning and other approaches to off-load the limbs of those with foot ulcers in order to reduce the mechanical loading on the foot during gait and promote ulcer healing.
Electronic supplementary material
The online version of this article (doi:10.1186/s12902-015-0057-7) contains supplementary material, which is available to authorized users.
doi:10.1186/s12902-015-0057-7
PMCID: PMC4619003  PMID: 26499881
Diabetic neuropathies; Diabetic foot; Foot ulcer; Longitudinal studies; Gait; Protocols; Plantar pressure
8.  The Influence of Beliefs About Health and Illness on Foot Care in Ugandan Persons with Diabetic Foot Ulcers 
The Open Nursing Journal  2013;7:123-132.
Diabetes mellitus is becoming pandemic, particularly affecting Sub-Saharan Africa, and the prevalence of complications is increasing. Diabetic foot disorders are a major source of morbidity and disability. Delay in the health care process due to patients’ beliefs may have deleterious consequences for limb and life in persons with diabetic foot ulcers. No previous studies of beliefs about health and illness in persons with diabetic foot ulcers living in Africa have been found. The aim of the study was to explore beliefs about health and illness among Ugandans with diabetic foot ulcers that might affect self-care and care seeking behaviour. In an explorative study with consecutive sample semi-structured interviews were held with 14 Ugandan men and women, aged 40-79, with diabetic foot ulcer. Knowledge was limited about causes, management and prevention of diabetic foot ulcers. Foot ulcers were often detected as painful sores, perceived to heal or improve, and led to stress and social isolation due to smell and reduced mobility. Most lacked awareness of the importance of complete daily foot care and seldom practised self-care. Health was described as absence of disease and pain. Many feared future health and related it to contact with nurses in the professional sector from whom they sought information, blood tests and wound dressings and desired better organised diabetes clinics offering health education and more opening hours. Many have an underutilised potential for self-care and need education urgently, delivered in well-organised diabetes clinics working to raise awareness of the threat and prevent foot ulcers.
doi:10.2174/1874434601307010123
PMCID: PMC3771228  PMID: 24039644
Africans; attitudes to health/illness; beliefs about health/illness; care-seeking behaviour; diabetes mellitus complications; foot ulcer; self-care.
9.  Comparison of demographic and clinical characteristics influencing health-related quality of life in patients with diabetic foot ulcers and those without foot ulcers 
Background
A number of studies have demonstrated that health-related quality of life (HRQoL) is negatively affected by diabetic foot ulcers. The aim of this study was to compare HRQoL in diabetic patients with and without foot ulcers and to determine demographic and clinical factors influencing HRQoL.
Methods
There were no variables affecting HRQoL except for gender in diabetic patients without foot ulcers. Demographic and clinical variables were recorded and HRQoL was evaluated using the Short Form 36 (SF-36) survey for all participants. The summary physical component score (PCS) and mental component score (MCS) and eight domains of HRQoL were compared in the two groups. Linear regression analysis was also used to investigate sociodemographic and clinical characteristics as predictors of quality of life as measured by SF-36.
Results
The overall score, PCS, and MCS, were significantly higher in patients without diabetic foot ulcers. Except for gender, none of the variables affected HRQoL in diabetic patients without foot ulcers. Male gender had a higher score in all domains of quality of life than female gender in diabetic patients without foot ulcers. Living alone, a low educational level, and having at least one complication were all associated with a lower HRQoL score in patients with foot ulcers. High-grade ulcers determined by Wagner’s classification and poor glycemic control as measured by HbA1C predicted HRQoL impairment in patients with diabetic foot ulcers.
Conclusion
Because Wagner’s grade was one of the strongest variables associated with HRQoL, this scale is recommended for monitoring of patients with diabetic foot ulcers in order to prevent continuing deterioration of HRQoL by treatment of foot ulcers at an earlier stage.
doi:10.2147/DMSO.S27050
PMCID: PMC3257967  PMID: 22253537
quality of life; diabetics; foot ulcer
10.  Depression symptoms in people with diabetes attending outpatient podiatry clinics for the treatment of foot ulcers 
Background
The purpose of this study was to examine the prevalence of depressive symptoms, diabetes self-management, and quality of life in people with diabetes and foot ulcers. Ulcer status, mortality and amputations were also assessed at six months follow-up.
Methods
This was a cross-sectional survey of people attending outpatient podiatry clinics at a major tertiary referral hospital. Depressive symptoms were measured using the Patient Health Questionnaire (PHQ). Diabetes self-care was assessed using the Summary of Diabetes Self Care Activities (SDSCA) measure. Health-related quality of life was measured using the physical component summary score (PCS) and the mental component summary score (MCS) of the SF-12.
Results
Of the 60 participants in the study 14 (23.3%) reported mild symptoms of depression (PHQ score 5–9) and 17 (28.3%) moderate to severe depressive symptoms (PHQ score > 9). Twenty-one (35%) met the criteria for previously recognized depression (on antidepressants and/or a diagnosis of depression in the last 12 months) and 17 (28.3%) for depression not previously recognized (PHQ > 4). Seventeen (28%) participants had been receiving antidepressant treatment for a median duration of 104 weeks (IQR 20, 494 weeks). Despite antidepressant treatment 12 participants (70.6% of those taking antidepressants) still reported moderate to severe depressive symptoms at the time of the study. Patients with PHQ scores > 4 reported poorer adherence to diabetes self-care activities including general diet, exercise, blood sugar monitoring and foot care when compared to those participants with PHQ scores < 5. No association was found between physical functioning (PCS) and depressive symptoms. Decreasing mental wellbeing (MCS) was associated with increasing depressive symptoms. At six months follow-up, there were three deaths and three amputations in participants with PHQ scores > 4 compared with no deaths and 2 amputations in participants with PHQ scores < 5. There was no association between depressive symptoms and ulcer healing or ulcer recurrence at the six-month follow-up.
Conclusions
This study found a high prevalence of depressive symptoms both recognized and unrecognized in people with diabetes and foot ulcers. Depressive symptoms were associated with overall poorer diabetes self-management and health-related quality of life (HRQoL). There was no association between depressive symptoms and ulcer outcomes at six-months follow-up.
doi:10.1186/s13047-014-0047-4
PMCID: PMC4245797  PMID: 25431624
Diabetes self-management; Depressive symptoms; Foot ulcers; PHQ-9; Antidepressants; Quality of life
11.  A clinical analysis of diabetic patients with hand ulcer in a diabetic foot centre 
Wang, C | Lv, L | Wen, X | Chen, D | Cen, S | Huang, H | Li, X | Ran, X
Diabetic Medicine  2010;27(7):848-851.
Aims
The aim of the study was to explore the prevalence and clinical characteristics of hand ulcer in hospitalized patients with diabetes.
Methods
We analysed 17 subjects with hand ulcer among diabetic inpatients, who were admitted to the Diabetic Foot Care Center, Department of Endocrinology and Metabolism at the West China Hospital of Sichuan University from April 2003 to December 2008.
Results
The prevalence of diabetic hand ulcer among hospitalized patients (0.37%) was significantly lower than that of diabetic foot ulcers (9.7%, P= 0.000). The mean age was 62.1 ± 9.4 years. The average known durations of diabetes and glycated haemoglobin (HbA1c) were 5.3 ± 4.9 years and 10.9 ± 2.4%, respectively. All patients lived in the subtropical zone. Fifteen patients (88.2%) were diagnosed with diabetic peripheral neuropathy. Ten patients had hand infection. After therapy, the ulcers healed in 13 patients (76.5%) and none of them experienced amputation. The average hospital stay for patients with local infection was characteristically longer than that for patients without infection (P= 0.012). The prognosis of the hand ulcer was poorer in the patients who had diabetes for > 3 years compared with those who had diabetes for < 3 years (P= 0.009).
Conclusions
Diabetic hand ulcer is a relatively rare complication of diabetes in South-West China. Long duration of diabetes, poorly controlled blood glucose, minor trauma and delayed treatment are the risk factors. Diabetic peripheral neuropathy may play an important role in the pathogenesis of hand ulcer. Early control of blood glucose with insulin and early anti-microbial therapy with appropriate antibiotics are crucial. Debridement and drainage are necessary for hand abscesses.
doi:10.1111/j.1464-5491.2010.03012.x
PMCID: PMC2905609  PMID: 20636968
diabetes mellitus; diabetic hand; hand ulcer; infection; therapy
12.  Factors associated with differences in perceived health among German long-term unemployed 
BMC Public Health  2012;12:485.
Background
Unemployment is associated with reduced physical and psychological well-being. Perceived health is an important factor influencing health outcomes as well as successful returns to work. This study aims to determine the extent to which perceived health correlates with mental health, various health risk characteristics and socio-demographic characteristics in a setting-selected sample of long-term unemployed persons.
Methods
Using SF-12, 365 long-term unemployed persons were assessed for self-perceived health and various socio-demographic and health characteristics. Perceived health data of the sample was compared to the German SF-12 reference population. Bivariate analyses and multiple linear regression models were applied to identify those variables significantly associated with perceived health.
Results
The study population reported poorer perceived health compared with the general population. Analyses showed that perceived mental health was significantly worse in women, among persons with heightened depression and anxiety scores, and in participants reporting reduced levels of physical activity. Perceived physical health was significantly lower among older persons, participants with a higher BMI, and participants with heightened depression and anxiety scores. Both mental and physical health were worse among the unemployed assigned to an employment center as compared to those engaged in the secondary labor market. In total, 36% of the variance in the SF-12 mental score and 20% of the variance in the SF-12 physical score were explained by the factors included in the final multiple linear regression models.
Conclusions
Perceived health among a select group of long-term unemployed is reduced to a clinically relevant extent compared to the general population. The preliminary findings underline an association between mental health and perceived health. Negative self-perceptions of health were also associated with the labor market setting and some of the socio-demographic and health behavior variables. Further research is needed to determine risk factors leading to reduced perceived health in the unemployed. The strong association between mental health and perceived health suggests interventions targeting mental health are urgently needed to positively influence perceived health, a key determinant of individuals’ chances to successfully return to work.
doi:10.1186/1471-2458-12-485
PMCID: PMC3403995  PMID: 22738028
Long-term unemployed; SF-12; HADS-Anxiety; HADS-Depression; Self-perceived health
13.  Mortality Risk of Charcot Arthropathy Compared With That of Diabetic Foot Ulcer and Diabetes Alone 
Diabetes Care  2009;32(5):816-821.
OBJECTIVE
The purpose of this study was to compare mortality risks of patients with Charcot arthropathy with those of patients with diabetic foot ulcer and those of patients with diabetes alone (no ulcer or Charcot arthropathy).
RESEARCH DESIGN AND METHODS
A retrospective cohort of 1,050 patients with incident Charcot arthropathy in 2003 in a large health care system was compared with patients with foot ulcer and those with diabetes alone. Mortality was determined during a 5-year follow-up period. Patients with Charcot arthropathy were matched to individuals in the other two groups using propensity score matching based on patient age, sex, race, marital status, diabetes duration, and diabetes control.
RESULTS
During follow-up, 28.0% of the sample died; 18.8% with diabetes alone and 37.0% with foot ulcer died compared with 28.3% with Charcot arthropathy. Multivariable Cox regression shows that, compared with Charcot arthropathy, foot ulcer was associated with 35% higher mortality risk (hazard ratio 1.35 [95% CI 1.18–1.54]) and diabetes alone with 23% lower risk (0.77 [0.66–0.90]). Of the patients with Charcot arthropathy, 63% experienced foot ulceration before or after the onset of the Charcot arthropathy. Stratified analyses suggest that Charcot arthropathy is associated with a significantly increased mortality risk independent of foot ulcer and other comorbidities.
CONCLUSIONS
Charcot arthropathy was significantly associated with higher mortality risk than diabetes alone and with lower risk than foot ulcer. Patients with foot ulcers tended to have a higher prevalence of peripheral vascular disease and macrovascular diseases than patients with Charcot arthropathy. This finding may explain the difference in mortality risks between the two groups.
doi:10.2337/dc08-1695
PMCID: PMC2671113  PMID: 19196882
14.  Health-related quality of life and all-cause mortality in patients with diabetes on dialysis 
BMC Nephrology  2012;13:78.
Background
This study tests the hypotheses that health-related quality of life (HRQOL) in prevalent dialysis patients with diabetes is lower than in dialysis patients without diabetes, and is at least as poor as diabetic patients with another severe complication, i.e. foot ulcers. This study also explores the mortality risk associated with diabetes in dialysis patients.
Methods
HRQOL was assessed using the Short Form-36 Health Survey (SF-36), in a cross-sectional study of 301 prevalent dialysis patients (26% with diabetes), and compared with diabetic patients not on dialysis (n = 221), diabetic patients with foot ulcers (n = 127), and a sample of the general population (n = 5903). Mortality risk was assessed using a Kaplan-Meier plot and Cox proportional hazards analysis.
Results
Self-assessed vitality, general and mental health, and physical function were significantly lower in dialysis patients with diabetes than in those without. Vitality (p = 0.011) and general health (p <0.001) was impaired in diabetic patients receiving dialysis compared to diabetic patients with foot ulcers, but other subscales did not differ. Diabetes was a significant predictor for mortality in dialysis patients, with a hazard ratio (HR) of 1.6 (95% CI 1.0-2.5) after adjustment for age, dialysis vintage and coronary artery disease. Mental aspects of HRQOL were an independent predictor of mortality in diabetic patients receiving dialysis after adjusting for age and dialysis vintage (HR 2.2, 95% CI 1.0-5.0).
Conclusions
Physical aspects of HRQOL were perceived very low in dialysis patients with diabetes, and lower than in other dialysis patients and diabetic patients without dialysis. Mental aspects predicted mortality in dialysis patients with diabetes. Increased awareness and measures to assist physical function impairment may be particularly important in diabetes patients on dialysis.
doi:10.1186/1471-2369-13-78
PMCID: PMC3483202  PMID: 22863310
Dialysis; Diabetes; Foot Ulcers; QOL; Mortality
15.  Comparing the Effects of Two Teaching Methods on Healing of Diabetic Foot Ulcer 
Journal of Caring Sciences  2012;1(1):17-24.
Introduction: Some studies have reported that diabetic patients do not adhere well to the foot care recommendations. Reasons for non-adherence are less evident and the methods used in education programs may have an effect. Therefore, the aim of the present study was to compare the effects of lecture method and combined method of education on foot care of patients and healing rates of diabetic foot ulcers. Methods: A matched controlled trial study was conducted on a sample of 45 diabetic patients with foot ulcers. The two intervention groups were taught with similar content but different methods. Patients’ foot care and healing rates of diabetic foot ulcers were assessed at the beginning of study and after 3 months in the two training groups as well as the control group. Results: Ulcer surface was decreased by 46%, 61% and 81.6% in the control, lecture group and com-bined group, respectively. The ulcer depth was also decreased by 66.7%, 97.5% and 69.1% in the three groups respectively. A significant relationship was observed between the group adherence of the self-care program and the amount of decrease in the ulcer surface area (r = 0.36, p = 0.04). Conclusion: The foot care education could significantly affect the healing of diabetic foot ulcer, especially in terms of the ulcers’ surface area. Therefore, a self-care education program should be integrated in the health system to empower those living with diabetes to manage their own foot appropriately.
doi:10.5681/jcs.2012.003
PMCID: PMC4166688  PMID: 25276671
Diabetic foot; Patient education; Self-care
16.  History of Foot Ulcer Increases Mortality Among Individuals With Diabetes 
Diabetes Care  2009;32(12):2193-2199.
OBJECTIVE
To compare mortality rates for individuals with diabetes with and without a history of foot ulcer (HFU) and with that for the nondiabetic population.
RESEARCH DESIGN AND METHODS
This population-based study included 155 diabetic individuals with an HFU, 1,339 diabetic individuals without an HFU, and 63,632 nondiabetic individuals who were all followed for 10 years with mortality as the end point.
RESULTS
During the follow-up period, a total of 49.0% of diabetic individuals with an HFU died, compared with 35.2% of diabetic individuals without an HFU and 10.5% of those without diabetes. In Cox regression analyses adjusted for age, sex, education, current smoking, and waist circumference, having an HFU was associated with more than a twofold (2.29 [95% CI 1.82–2.88]) hazard risk for mortality compared with that of the nondiabetic group. In corresponding analyses comparing diabetic individuals with and without an HFU, an HFU was associated with 47% increased mortality (1.47 [1.14–1.89]). Significant covariates were older age, male sex, and current smoking. After inclusion of A1C, insulin use, microalbuminuria, cardiovascular disease, and depression scores in the model, each was significantly related to life expectancy.
CONCLUSIONS
AN HFU increased mortality risk among community-dwelling adults and elderly individuals with diabetes. The excess risk persisted after adjustment for comorbidity and depression scores, indicating that close clinical monitoring might be warranted among individuals with an HFU, who may be particularly vulnerable to adverse outcomes.
doi:10.2337/dc09-0651
PMCID: PMC2782976  PMID: 19729524
17.  Are Foot Abnormalities More Common in Adults with Diabetes? A Cross-Sectional Study in Basrah, Iraq 
The Permanente Journal  2008;12(4):25-30.
Background: Altered foot biomechanics, limited joint mobility, and bony deformities with neuropathy, peripheral vascular disease, and infection have been associated with an increased risk of ulceration and amputation among patients with diabetes. The aim of our study was to estimate prevalence of foot abnormalities among Iraqis with diabetes and to see if they are more common than in a control population.
Methods: We structured the study as a comparative outpatient clinic study. The study population consisted of 100 patients with type 2 diabetes and 100 patients without diabetes as the control group. The study was conducted between January 2006 and August 2007. The patients and study control subjects were selected from the outpatient clinic at Al-Faiha Hospital in Basrah, southern Iraq. All were adults of at least 40 years of age.
Results: There were no differences between the two groups regarding sex, age, weight, qualifications, smoking status, marital status, or residency, but patients with diabetes had a higher body mass index and a higher socioeconomic status. No differences were found in the type of footwear worn or in occupation. Foot abnormalities associated with diabetes were prominent metatarsal heads, hammertoe, high medial arch, wasting, joint stiffness, amputation, fissures, nail changes, ulcer, and dermopathy on univariate analysis. With a multivariable model using logistic regression, only wasting (odds ratio [OR], 0.21; 95% confidence interval [CI], 2.16–11.33; p = 0.0002), ulcer (OR, 0.08; 95% CI, 1.12–134.59; p = 0.03), and dryness (OR, 0.11; 95% CI; 1.19–7.32; p = 0.01) remained significantly associated with diabetes.
Conclusion: We checked for 17 foot abnormalities associated with diabetes and found that 13—prominent metatarsal head, high medial arch, hammertoe, wasting, joint stiffness, amputation, fissures, nail changes, ulcers, blisters, dryness, sclerosis, and dermopathy—were statistically more frequent in study participants with diabetes than in control study subjects without diabetes. In a logistic regression model, only wasting, ulcer, and dryness remained strongly associated with diabetes. A larger study is needed to see the relationship of these abnormalities with footwear worn, duration of wearing footwear, occupation, duration of diabetes, and insulin use.
PMCID: PMC3037137  PMID: 21339918
18.  Higher levels of psychological distress are associated with a higher risk of incident diabetes during 18 year follow-up: results from the British household panel survey 
BMC Public Health  2012;12:1109.
Background
Reviews have shown that depression is a risk factor for the development of type 2 diabetes. However, there is limited evidence for general psychological distress to be associated with incident diabetes. The aim of the present study was to test whether persons who report higher levels of psychological distress are at increased risk to develop type 2 diabetes during 18 years follow up, adjusted for confounders.
Methods
A prospective analysis using data from 9,514 participants (41 years, SD=14; 44% men) of the British Household Panel Survey. The General Health Questionnaire 12 item version was used to assess general psychological distress, diabetes was measured by means of self-report. Cox proportional hazards regression models were used to calculate the multivariate-adjusted hazard ratio (HR) of incident diabetes during 18 years follow up, comparing participants with low versus high psychological distress at baseline (1991).
Results
A total of 472 participants developed diabetes 18 year follow up. Those with a high level of psychological distress had a 33% higher hazard of developing diabetes (HR=1.33, 95% CI 1.10–1.61), relative to those with a low level of psychological distress, adjusted for age, sex, education level and household income. After further adjustment for differences in level of energy, health status, health problems and activity level, higher psychological distress was no longer associated with incident diabetes (HR=1.10, 95% CI 0.91-1.34).
Conclusions
Higher levels of psychological distress are a risk factor for the development of diabetes during an 18 year follow up period. This association may be potentially mediated by low energy level and impaired health status.
doi:10.1186/1471-2458-12-1109
PMCID: PMC3551824  PMID: 23259455
Type 2 diabetes; Psychological distress; Prospective; Risk factor; British household panel survey
19.  The Impact of Religious Connectedness on Health-Related Quality of Life in Patients with Diabetic Foot Ulcers 
Journal of Religion and Health  2011;52(3):840-850.
Religious connectedness is common phenomenon in Saudi Arabia and adjacent Gulf countries. An observational case control study was designed, enrolling 180 adult patients to report the association between religious connectedness and health-related quality of life (HRQL) in people with and without diabetes and foot ulcers. Sixty diabetic patients with foot ulcers (Group I) were compared with sixty diabetic patients without foot ulcer (Group II) and sixty healthy subjects (Group III) for assessment of their HRQL by using SF-36 questionnaire. The effect of religious connectedness was assessed using intrinsic/extrinsic religious connectedness scale. HRQL was found to be significantly lower in Group I compared with Group II and III as well as in group II compared with group III (P < 0.001). Group I patients showed a poorer HRQL with increased severity, duration and multiplicity of foot ulcers. There was a strong positive relationship between religious connectedness and HRQL as indicated by a positive correlation between religious connectedness scale and mental, physical component summary scores (r = 0.66 and 0.59 respectively and P < 0.001). While quality of life is generally poor in people with diabetic foot ulcers, there exists a strong positive relationship between religious connectedness and higher HRQL. These findings may have implications on improving outcomes.
doi:10.1007/s10943-011-9529-x
PMCID: PMC3695669  PMID: 21863475
Diabetes; Foot ulcers; Religious; Connectedness
20.  Patients' perspectives on foot complications in type 2 diabetes: a qualitative study 
Background
Foot ulceration is a major health problem for people with diabetes. To minimise the risk of ulceration, patients are advised to perform preventive foot self-care.
Aim
To explore beliefs about diabetic foot complications and everyday foot self-care practices among people with type 2 diabetes.
Design of study
Qualitative study using one-to-one interviews.
Setting
A suburban primary care health centre.
Method
Semi-structured interviews with a purposive sample of adults with type 2 diabetes but with no experience of foot ulceration.
Results
Most participants were unsure of what a foot ulcer is and unaware of the difficulties associated with ulcer healing. Prevention of accidental damage to the skin was not considered a priority, as few participants knew that this is a common cause of foot ulceration. Although it was recognised that lower-limb amputation is more common in people with diabetes, this was perceived to be predominantly caused by poor blood supply to the feet and unrelated to foot ulceration. Therefore, preventive foot care focused on stimulating blood circulation, for example by walking barefoot. Consequently, some of the behaviours participants considered beneficial for foot health could potentially increase the risk of ulceration. In some cases the uptake of advice regarding preventive foot care was hampered because participants found it difficult to communicate with health professionals.
Conclusion
Patients with type 2 diabetes may have beliefs about foot complications that differ from medical evidence. Such illness beliefs may play a role in foot-related behaviours that have previously been unrecognised. Health professionals need to explore and address the beliefs underlying patients' foot self-care practices.
doi:10.3399/bjgp08X319657
PMCID: PMC2566520  PMID: 18682014
diabetes mellitus; foot complications; foot self-care; illness beliefs; ulcer prevention
21.  Educational disparities in health behaviors among patients with diabetes: the Translating Research Into Action for Diabetes (TRIAD) Study 
BMC Public Health  2007;7:308.
Background
Our understanding of social disparities in diabetes-related health behaviors is incomplete. The purpose of this study was to determine if having less education is associated with poorer diabetes-related health behaviors.
Methods
This observational study was based on a cohort of 8,763 survey respondents drawn from ~180,000 patients with diabetes receiving care from 68 provider groups in ten managed care health plans across the United States. Self-reported survey data included individual educational attainment ("education") and five diabetes self-care behaviors among individuals for whom the behavior would clearly be indicated: foot exams (among those with symptoms of peripheral neuropathy or a history of foot ulcers); self-monitoring of blood glucose (SMBG; among insulin users only); smoking; exercise; and certain diabetes-related health seeking behaviors (use of diabetes health education, website, or support group in last 12 months). Predicted probabilities were modeled at each level of self-reported educational attainment using hierarchical logistic regression models with random effects for clustering within health plans.
Results
Patients with less education had significantly lower predicted probabilities of being a non-smoker and engaging in regular exercise and health-seeking behaviors, while SMBG and foot self-examination did not vary by education. Extensive adjustment for patient factors revealed no discernable confounding effect on the estimates or their significance, and most education-behavior relationships were similar across sex, race and other patient characteristics. The relationship between education and smoking varied significantly across age, with a strong inverse relationship in those aged 25–44, modest for those ages 45–64, but non-evident for those over 65. Intensity of disease management by the health plan and provider communication did not alter the examined education-behavior relationships. Other measures of socioeconomic position yielded similar findings.
Conclusion
The relationship between educational attainment and health behaviors was modest in strength for most behaviors. Over the life course, the cumulative effect of reduced practice of multiple self-care behaviors among less educated patients may play an important part in shaping the social health gradient.
doi:10.1186/1471-2458-7-308
PMCID: PMC2238766  PMID: 17967177
22.  Management of Chronic Pressure Ulcers 
Executive Summary
In April 2008, the Medical Advisory Secretariat began an evidence-based review of the literature concerning pressure ulcers.
Please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/tech/tech_mn.html to review these titles that are currently available within the Pressure Ulcers series.
Pressure ulcer prevention: an evidence based analysis
The cost-effectiveness of prevention strategies for pressure ulcers in long-term care homes in Ontario: projections of the Ontario Pressure Ulcer Model (field evaluation)
Management of chronic pressure ulcers: an evidence-based analysis
Objective
The Medical Advisory Secretariat (MAS) conducted a systematic review on interventions used to treat pressure ulcers in order to answer the following questions:
Do currently available interventions for the treatment of pressure ulcers increase the healing rate of pressure ulcers compared with standard care, a placebo, or other similar interventions?
Within each category of intervention, which one is most effective in promoting the healing of existing pressure ulcers?
Background
A pressure ulcer is a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in conjunction with shear and/or friction. Many areas of the body, especially the sacrum and the heel, are prone to the development of pressure ulcers. People with impaired mobility (e.g., stroke or spinal cord injury patients) are most vulnerable to pressure ulcers. Other factors that predispose people to pressure ulcer formation are poor nutrition, poor sensation, urinary and fecal incontinence, and poor overall physical and mental health.
The prevalence of pressure ulcers in Ontario has been estimated to range from a median of 22.1% in community settings to a median of 29.9% in nonacute care facilities. Pressure ulcers have been shown to increase the risk of mortality among geriatric patients by as much as 400%, to increase the frequency and duration of hospitalization, and to decrease the quality of life of affected patients. The cost of treating pressure ulcers has been estimated at approximately $9,000 (Cdn) per patient per month in the community setting. Considering the high prevalence of pressure ulcers in the Ontario health care system, the total cost of treating pressure ulcers is substantial.
Technology
Wounds normally heal in 3 phases (inflammatory phase, a proliferative phase of new tissue and matrix formation, and a remodelling phase). However, pressure ulcers often fail to progress past the inflammatory stage. Current practice for treating pressure ulcers includes treating the underlying causes, debridement to remove necrotic tissues and contaminated tissues, dressings to provide a moist wound environment and to manage exudates, devices and frequent turning of patients to provide pressure relief, topical applications of biologic agents, and nutritional support to correct nutritional deficiencies. A variety of adjunctive physical therapies are also in use.
Method
Health technology assessment databases and medical databases were searched from 1996 (Medline), 1980 (EMBASE), and 1982 (CINAHL) systematically up to March 2008 to identify randomized controlled trials (RCTs) on the following treatments of pressure ulcers: cleansing, debridement, dressings, biological therapies, pressure-relieving devices, physical therapies, nutritional therapies, and multidisciplinary wound care teams. Full literature search strategies are reported in appendix 1. English-language studies in previous systematic reviews and studies published since the last systematic review were included if they had more than 10 subjects, were randomized, and provided objective outcome measures on the healing of pressure ulcers. In the absence of RCTs, studies of the highest level of evidence available were included. Studies on wounds other than pressure ulcers and on surgical treatment of pressure ulcers were excluded. A total of 18 systematic reviews, 104 RCTs, and 4 observational studies were included in this review.
Data were extracted from studies using standardized forms. The quality of individual studies was assessed based on adequacy of randomization, concealment of treatment allocation, comparability of groups, blinded assessment, and intention-to-treat analysis. Meta-analysis to estimate the relative risk (RR) or weighted mean difference (WMD) for measures of healing was performed when appropriate. A descriptive synthesis was provided where pooled analysis was not appropriate or not feasible. The quality of the overall evidence on each intervention was assessed using the grading of recommendations assessment, development, and evaluation (GRADE) criteria.
Findings
Findings from the analysis of the included studies are summarized below:
Cleansing
There is no good trial evidence to support the use of any particular wound cleansing solution or technique for pressure ulcers.
Debridement
There was no evidence that debridement using collagenase, dextranomer, cadexomer iodine, or maggots significantly improved complete healing compared with placebo.
There were no statistically significant differences between enzymatic or mechanical debridement agents with the following exceptions:
Papain urea resulted in better debridement than collagenase.
Calcium alginate resulted in a greater reduction in ulcer size compared to dextranomer.
Adding streptokinase/streptodornase to hydrogel resulted in faster debridement.
Maggot debridement resulted in more complete debridement than conventional treatment.
There is limited evidence on the healing effects of debridement devices.
Dressings
Hydrocolloid dressing was associated with almost three-times more complete healing compared with saline gauze.
There is evidence that hydrogel and hydropolymer may be associated with 50% to 70% more complete healing of pressure ulcers than hydrocolloid dressing.
No statistically significant differences in complete healing were detected among other modern dressings.
There is evidence that polyurethane foam dressings and hydrocellular dressings are more absorbent and easier to remove than hydrocolloid dressings in ulcers with moderate to high exudates.
In deeper ulcers (stage III and IV), the use of alginate with hydrocolloid resulted in significantly greater reduction in the size of the ulcers compared to hydrocolloid alone.
Studies on sustained silver-releasing dressing demonstrated a tendency for reducing the risk of infection and promoting faster healing, but the sample sizes were too small for statistical analysis or for drawing conclusions.
Biological Therapies
The efficacy of platelet-derived growth factors (PDGFs), fibroblast growth factor, and granulocyte-macrophage colony stimulating factor in improving complete healing of chronic pressure ulcers has not been established.
Presently only Regranex, a recombinant PDGF, has been approved by Health Canada and only for treatment of diabetic ulcers in the lower extremities.
A March 2008 US Food and Drug Administration (FDA) communication reported increased deaths from cancers in people given three or more prescriptions for Regranex.
Limited low-quality evidence on skin matrix and engineered skin equivalent suggests a potential role for these products in healing refractory advanced chronic pressure ulcers, but the evidence is insufficient to draw a conclusion.
Adjunctive Physical Therapy
There is evidence that electrical stimulation may result in a significantly greater reduction in the surface area and more complete healing of stage II to IV ulcers compared with sham therapy. No conclusion on the efficacy of electrotherapy can be drawn because of significant statistical heterogeneity, small sample sizes, and methodological flaws.
The efficacy of other adjunctive physical therapies [electromagnetic therapy, low-level laser (LLL) therapy, ultrasound therapy, ultraviolet light therapy, and negative pressure therapy] in improving complete closure of pressure ulcers has not been established.
Nutrition Therapy
Supplementation with 15 grams of hydrolyzed protein 3 times daily did not affect complete healing but resulted in a 2-fold improvement in Pressure Ulcer Scale for Healing (PUSH) score compared with placebo.
Supplementation with 200 mg of zinc three times per day did not have any significant impact on the healing of pressure ulcers compared with a placebo.
Supplementation of 500 mg ascorbic acid twice daily was associated with a significantly greater decrease in the size of the ulcer compared with a placebo but did not have any significant impact on healing when compared with supplementation of 10 mg ascorbic acid three times daily.
A very high protein tube feeding (25% of energy as protein) resulted in a greater reduction in ulcer area in institutionalized tube-fed patients compared with a high protein tube feeding (16% of energy as protein).
Multinutrient supplements that contain zinc, arginine, and vitamin C were associated with a greater reduction in the area of the ulcers compared with standard hospital diet or to a standard supplement without zinc, arginine, or vitamin C.
Firm conclusions cannot be drawn because of methodological flaws and small sample sizes.
Multidisciplinary Wound Care Teams
The only RCT suggests that multidisciplinary wound care teams may significantly improve healing in the acute care setting in 8 weeks and may significantly shorten the length of hospitalization. However, since only an abstract is available, study biases cannot be assessed and no conclusions can be drawn on the quality of this evidence.
PMCID: PMC3377577  PMID: 23074533
23.  Baseline characteristics and risk factors for ulcer, amputation and severe neuropathy in diabetic foot at risk: the BRAZUPA study 
Background
Studies on diabetic foot and its complications involving a significant and representative sample of patients in South American countries are scarce. The main objective of this study was to acquire clinical and epidemiological data on a large cohort of diabetic patients from 19 centers from Brazil and focus on factors that could be associated with the risk of ulcer and amputation.
Methods
This study presents cross sectional, baseline results of the BRAZUPA Study. A total of 1455 patients were included. Parameters recorded included age, gender, ethnicity, diabetes and comorbidity-related records, previous ulcer or amputation, clinical symptomatic score, foot classification and microvascular complications.
Results
Patients with ulcer had longer disease duration (17.2 ± 9.9 vs. 13.2 ± 9.4 years; p < 0.001), and poorer glycemic control (HbA1c 9.23 ± 2.03 vs. 8.35 ± 1.99; p < 0.001). Independent risk factors for ulcer were male gender (OR 1.71; 95 % CI 1.2–3.7), smoking (OR 1.78; 95 % CI 1.09–2.89), neuroischemic foot (OR 20.34; 95 % CI 9.31–44.38), region of origin (higher risk for those from developed regions, OR 2.39; 95 % CI 1.47–3.87), presence of retinopathy (OR 1.68; 95 % CI 1.08–2.62) and absence of vibratory sensation (OR 7.95; 95 % CI 4.65–13.59). Risk factors for amputation were male gender (OR 2.12; 95 % CI 1.2–3.73), type 2 diabetes (OR 3.33; 95 % CI 1.01–11.1), foot at risk classification (higher risk for ischemic foot, OR 19.63; 95 % CI 3.43–112.5), hypertension (lower risk, OR 0.3; 95 % CI 0.14–0.63), region of origin (South/Southeast, OR 2.2; 95 % CI 1.1–4.42), previous history of ulcer (OR 9.66; 95 % CI 4.67–19.98) and altered vibratory sensation (OR 3.46; 95 % CI 1.64–7.33). There was no association between either outcome and ethnicity.
Conclusions
Ulcer and amputation rates were high. Age at presentation was low and patients with ulcer presented a higher prevalence of neuropathy compared to ischemic foot at risk. Ischemic disease was more associated with amputations. Ethnical differences were not of great importance in a miscegenated population.
doi:10.1186/s13098-016-0126-8
PMCID: PMC4794830  PMID: 26989446
Diabetes; Risk factors for ulcer; Amputation; Severe neuropathy; Brazil
24.  Dialysis Treatment Is an Independent Risk Factor for Foot Ulceration in Patients With Diabetes and Stage 4 or 5 Chronic Kidney Disease 
Diabetes Care  2010;33(8):1811-1816.
OBJECTIVE
To determine whether dialysis treatment is an independent risk factor for foot ulceration in patients with diabetes and renal impairment.
RESEARCH DESIGN AND METHODS
We performed a cross-sectional study of consecutive patients with diabetes and stage 4 or 5 chronic kidney disease (CKD) attending clinics in Manchester (U.K.). Patients were classified as either receiving dialysis therapy (dialysis) or not (no dialysis). Foot assessment included diabetic peripheral neuropathy (DPN), peripheral arterial disease (PAD), prior foot ulceration and amputation, and foot self-care. Risk factors for prevalent foot ulceration were assessed by logistic regression.
RESULTS
We studied 326 patients with diabetes and CKD (mean age 64 years; 61% male; 78% type 2 diabetes; 11% prevalent foot ulceration). Compared with no dialysis patients, dialysis patients had a higher prevalence of DPN (79 vs. 65%), PAD (64 vs. 43%), prior amputations (15 vs. 6.4%), prior foot ulceration (32 vs. 20%), and prevalent foot ulceration (21 vs. 5%, all P < 0.05). In univariate analyses, foot ulceration was related to wearing bespoke footwear (odds ratio 5.6 [95% CI 2.5–13]) dialysis treatment (5.1 [2.3–11]), prior foot ulceration (4.8 [2.3–9.8], PAD (2.8 [1.3–6.0], and years of diabetes (1.0 [1.0–1.1], all P < 0.01). In multivariate logistic regression, only dialysis treatment (4.2 [1.7–10], P = 0.002) and prior foot ulceration (3.1 [1.3–7.1], P = 0.008) were associated with prevalent foot ulceration.
CONCLUSIONS
Dialysis treatment was independently associated with foot ulceration. Guidelines should highlight dialysis as an important risk factor for foot ulceration requiring intensive foot care.
doi:10.2337/dc10-0255
PMCID: PMC2909067  PMID: 20484126
25.  Determine the relationship between perceived social support and depression level of patients with diabetic foot 
Background
As a lifelong disease, diabetes impairs the quality of life by limiting the eating and drinking habits and by bringing out the risk of kidney, eye, cardiovascular and diabetic neurological diseases in the long run. Loss of health might result in mourning, grief, rebellion, denial, anxiety, rage and sometimes these feelings might overcome the patient’s coping skills leading to depression [Clinical Psychiatry 11 (Suppl 3) 3-18, 2008]. How individuals suffering from depression perceive and interpret the incidents around them is also important [Rel. Scie. Acad. J. III, 2: 129-152, 2003]. Accordingly, the determination of the correlation of the depression with the perceived social support level by the patients with diabetic foot was programmed and performed in order to take essential precautions, to generate proper solutions and treatment process and to make supportive plans for patients with developing diabetic foot and depression.
Methods
The data was obtained from 128 patients who applied to hospital within the scope of research between July 1st 2011 and January 31st 2012 that were diagnosed with diabetes and had diabetic foot. Pearson chi-square, Fisher Exact and Likelihood ratio, chi-square, Student t test and one way analysis of variance, Levene’ s test, One way ANOVA, Welch and Games Howell tests were used in the analysis and evaluation. The data was collected by meeting face to face the individuals and by making use of the patient files and using the “Personal Information Form” which includes introductory information about individuals with diabetic foot, “Beck Depression Scale” which is applied to determine emotion status of individuals and “Multidimensional Scale of Perceived Social Support” which is applied to determine the level of social support individuals perceive.
Results
In the performed statistical evaluation, mean scores of Beck Depression scale and MSPSS family support, friend support, special person support sub-dimension and scale total scores were found to be in negative statistical correlation (p < 0.01).
Conclusions
In the treatment and care of the patients with diabetic foot; anxiety and depression status of the patients, as well as physical status, should also be evaluated routinely. The individuals provided to take professional care.
doi:10.1186/s40200-015-0168-8
PMCID: PMC4511528  PMID: 26203429
Diabetes; Diabetic foot; Depression; Social support

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