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1.  The management of neuropathic ulcers of the foot in diabetes by shock wave therapy 
Background
Diabetes is becoming one of the most common chronic diseases, and ulcers are its most serious complication. Beginning with neuropathy, the subsequent foot wounds frequently lead to lower extremity amputation, even in the absence of critical limb ischemia. In recent years, some researchers have studied external shock wave therapy (ESWT) as a new approach to soft tissue wound healing. The rationale of this study was to evaluate if ESWT is effective in the management of neuropathic diabetic foot ulcers.
Methods
We designed a randomized, prospective, controlled study in which we recruited 30 patients affected by neuropathic diabetic foot ulcers and then divided them into two groups based on different management strategies. One group was treated with standard care and shock wave therapy. The other group was treated with only standard care. The healing of the ulcers was evaluated over 20 weeks by the rate of re-epithelization.
Results
After 20 weeks of treatment, 53.33% of the ESWT-treated patients had complete wound closure compared with 33.33% of the control patients, and the healing times were 60.8 and 82.2 days, respectively (p < 0.001). Significant differences in the index of the re-epithelization were observed between the two groups, with values of 2.97 mm2/die in the ESWT-group and 1.30 mm2/die in the control group (p < 0.001).
Conclusion
Therefore, ESWT may be a useful adjunct in the management of diabetic foot ulceration.
Trial registration
Current Controlled Trials ISRCTN21800909
doi:10.1186/1471-2474-10-54
PMCID: PMC2693140  PMID: 19473538
2.  Neuropathic diabetic foot ulcers – evidence-to-practice 
Foot ulcers and their attendant complications are disquietingly high in people with diabetes, a majority of whom have underlying neuropathy. This review examines the evidence base underpinning the prevention and management of neuropathic diabetic foot ulcers in order to inform best clinical practice. Since it may be impractical to ask patients not to weight-bear at all, relief of pressure through the use of offloading casting devices remains the mainstay for management of neuropathic ulcers, whilst provision of appropriate footwear is essential in ulcer prevention. Simple non-surgical debridement and application of hydrogels are both effective in preparing the wound bed for healthy granulation and therefore enhancing healing. Initial empirical antibiotic therapy for infected ulcers should cover the most common bacterial flora. There is limited evidence supporting the use of adjunctive therapies such as hyperbaric oxygen and cytokines or growth factors. In selected cases, recombinant human platelet-derived growth factor has been shown to enhance healing; however, its widespread use cannot be advised due to the availability of more cost-effective approaches. While patient education may be beneficial, the evidence base remains thin and conflicting. In conclusion, best management of foot ulcers is achieved by what is taken out of the foot (pressure, callus, infection, and slough) rather than what is put on the foot (adjuvant treatment).
Video abstract
Video
doi:10.2147/IJGM.S10328
PMCID: PMC3282596  PMID: 22371655
diabetic foot ulcers; neuropathic foot ulcers; foot ulcers
3.  Commentary on the Conversion to an Advanced Standard of Care for the Treatment of Diabetic Foot Ulcers and Other Chronic Wounds 
There have been notable contributions in the literature regarding the consensus for a new standard for the treatment of diabetic foot ulcers. The more recent advances in wound care therapies, modalities, and evidence-based research have demonstrated that an advanced standard of care for wound healing should exist. Failure of treatment protocols, which center on a 50% area of wound reduction within 4 weeks as a response to standard conventional care, should indicate the use of adjuvant therapies. Negative pressure wound therapy (NPWT), hyperbaric oxygen therapy (HBOT), growth factors, human-derived bioengineered tissue, and extracellular matrix products are readily available. This commentary will explore a brief selection of the current wound care literature as it relates to the acceptance of a new advanced standard of care. Furthermore, the intention is to stimulate further discussion and thought on the relevance of this approach in the treatment of diabetic foot ulcers and chronic wounds and how it may correlate with the ultimate outcome of healing in general.
doi:10.1016/j.jcws.2010.09.003
PMCID: PMC3601923  PMID: 24527143
Adjuvant therapy; Advanced standard of care; Bioengineered tissue; Chronic wounds; Diabetic ulcers; Extracellular matrix; HBOT; NPWT; Standard of care; Timely wound care; Wound healing; Wound management
4.  A review of becaplermin gel in the treatment of diabetic neuropathic foot ulcers 
Diabetic neuropathic foot ulcers represent a serious health care burden to patients and to society. While the management of chronic diabetic foot ulcers has improved in recent years, it remains a frustrating problem for a variety of clinicians. This review examines the scientific underpinnings supporting the use of becaplermin (Regranex®; Ortho-McNeil Pharmaceutical, Raritan, NJ), or recombinant human platelet-derived growth factor (rhPDGF-BB), in diabetic forefoot wounds. An emphasis is placed upon proper medical and surgical care of diabetic foot wounds, as multiple studies have demonstrated that the success of this growth factor in accelerating healing is ultimately dependent on proper ulcer care. A focus on the cost-effectiveness of this form of therapy in the treatment of diabetic foot ulcers is also outlined.
PMCID: PMC2727777  PMID: 19707423
becaplermin; diabetes; foot ulcer; growth factor
5.  Effectiveness of foot care education among people with type 2 diabetes in rural Puducherry, India 
Background:
The burden of diabetes and its foot complications is increasing in India. Prevention of these complications through foot care education should be explored. The objective of our study was to assess the risk factors of poor diabetic foot care and to find the effectiveness of health education in improving foot care practice among diabetes patients.
Materials and Methods:
A structured pre-tested questionnaire was administered to the outpatients of a rural health center with type 2 diabetes. Awareness regarding diabetes, care of diabetes and foot care practice ware assessed and scored. Individual and group health education focusing on foot care was performed. Foot care practice was reassessed after 2 weeks of education.
Results:
Only 54% were aware that diabetes could lead to reduced foot sensation and foot ulcers. Nearly 53% and 41% of the patients had good diabetes awareness and good diabetes care respectively. Only 22% of the patients had their feet examined by a health worker or doctor. The patients with poor, satisfactory and good practice scores were 44.7%, 35.9% and 19.4% respectively. Low education status, old age and low awareness regarding diabetes were the risk factors for poor practice of foot care. Average score for practice of foot care improved from 5.90 ± 1.82 to 8.0 ± 1.30 after 2 weeks of health education. Practice related to toe space examination, foot inspection and foot wear inspection improved maximally.
Conclusion:
Foot care education for diabetics in a primary care setting improves their foot care practice and is likely to be effective in reducing the burden of diabetic foot ulcer.
doi:10.4103/2230-8210.126587
PMCID: PMC3968714  PMID: 24701439
Diabetes; diabetic foot ulcer; foot care; health education; India
6.  Contemporary Evaluation and Management of the Diabetic Foot 
Scientifica  2012;2012:435487.
Foot problems in patients with diabetes remain a major public health issue and are the commonest reason for hospitalization of patients with diabetes with prevalence as high as 25%. Ulcers are breaks in the dermal barrier with subsequent erosion of underlying subcutaneous tissue that may extend to muscle and bone, and superimposed infection is a frequent and costly complication. The pathophysiology of diabetic foot disease is multifactorial and includes neuropathy, infection, ischemia, and abnormal foot structure and biomechanics. Early recognition of the etiology of these foot lesions is essential for good functional outcome. Managing the diabetic foot is a complex clinical problem requiring a multidisciplinary collaboration of health care workers to achieve limb salvage. Adequate off-loading, frequent debridement, moist wound care, treatment of infection, and revascularization of ischemic limbs are the mainstays of therapy. Even when properly managed, some of the foot ulcers do not heal and are arrested in a state of chronic inflammation. These wounds can frequently benefit from various adjuvants, such as aggressive debridement, growth factors, bioactive skin equivalents, and negative pressure wound therapy. While these, increasingly expensive, therapies have shown promising results in clinical trials, the results have yet to be translated into widespread clinical practice leaving a huge scope for further research in this field.
doi:10.6064/2012/435487
PMCID: PMC3820495  PMID: 24278695
7.  Foot ulcers in the diabetic patient, prevention and treatment 
Lower extremity complications in persons with diabetes have become an increasingly significant public health concern in both the developed and developing world. These complications, beginning with neuropathy and subsequent diabetic foot wounds frequently lead to infection and lower extremity amputation even in the absence of critical limb ischemia. In order to diminish the detrimental consequences associated with diabetic foot ulcers, a com-mon-sense-based treatment approach must be implemented. Many of the etiological factors contributing to the formation of diabetic foot ulceration may be identified using simple, inexpensive equipment in a clinical setting. Prevention of diabetic foot ulcers can be accomplished in a primary care setting with a brief history and screening for loss of protective sensation via the Semmes-Weinstein monofilament. Specialist clinics may quantify neuropathy, plantar foot pressure, and assess vascular status with Doppler ultrasound and ankle-brachial blood pressure indices. These measurements, in conjunction with other findings from the history and physical examination, may enable clinicians to stratify patients based on risk and help determine the type of intervention. Other effective clinical interventions may include patient education, optimizing glycemic control, smoking cessation, and diligent foot care. Recent technological advanced combined with better understanding of the wound healing process have resulted in a myriad of advanced wound healing modalities in the treatment of diabetic foot ulcers. However, it is imperative to remember the fundamental basics in the healing of diabetic foot ulcers: adequate perfusion, debridement, infection control, and pressure mitigation. Early recognition of the etiological factors along with prompt management of diabetic foot ulcers is essential for successful outcome.
PMCID: PMC1994045  PMID: 17583176
diabetes; ulcer; prevention; infection; amputation
8.  Low Level Laser Therapy for the Treatment of Diabetic Foot Ulcers: A Critical Survey 
Diabetic foot ulcers as one of the most common complications of diabetes mellitus are defined as nonhealing or long-lasting chronic skin ulcers in diabetic patients. Multidisciplinary care for the diabetic foot is common, but treatment results are often unsatisfactory. Low level laser therapy (LLLT) on wound areas as well as on acupuncture points, as a noninvasive, pain-free method with minor side effects, has been considered as a possible treatment option for the diabetic foot syndrome. A systematic literature review identified 1764 articles on this topic. Finally, we adopted 22 eligible references; 8 of them were cell studies, 6 were animal studies, and 8 were clinical trials. Cell studies and animal studies gave evidence of cellular migration, viability, and proliferation of fibroblast cells, quicker reepithelization and reformed connective tissue, enhancement of microcirculation, and anti-inflammatory effects by inhibition of prostaglandine, interleukin, and cytokine as well as direct antibacterial effects by induction of reactive oxygen species (ROS). The transferral of these data into clinical medicine is under debate. The majority of clinical studies show a potential benefit of LLLT in wound healing of diabetic ulcers. But there are a lot of aspects in these studies limiting final evidence about the actual output of this kind of treatment method. In summary, all studies give enough evidence to continue research on laser therapy for diabetic ulcers, but clinical trials using human models do not provide sufficient evidence to establish the usefulness of LLLT as an effective tool in wound care regimes at present. Further well designed research trials are required to determine the true value of LLLT in routine wound care.
doi:10.1155/2014/626127
PMCID: PMC3976827  PMID: 24744814
9.  Diabetic foot disease in the United Kingdom: about time to put feet first 
Diabetes is now the biggest cause of amputation, stroke, blindness and end stage renal failure. It causes many deaths from cardiovascular disease. Foot ulcers and amputations reduce the quality of life, increase mortality and involve lengthy stay in hospital. Many people who have an ulcer eventually require surgery. The economic cost to the nation is spiralling out of control with estimates of 10% of the entire NHS budget spent on diabetes. This paper aims to explore the burden of diabetic complications and how policy, guidelines and audit highlight the discrepancies in the quality of diabetes care with particular reference to diabetes foot services. The findings suggest that the NICE guidelines for diabetes foot care are not being adhered to and that the variation in preventative amputations across England is unacceptable. Diabetes UK, the national charity for diabetes is leading a campaign to improve diabetic foot care in light of the available published health information.
doi:10.1186/1757-1146-5-26
PMCID: PMC3488016  PMID: 23050905
10.  Diabetic foot ulcers. Pathophysiology, assessment, and therapy. 
Canadian Family Physician  2001;47:1007-1016.
OBJECTIVE: To review underlying causes of diabetic foot ulceration, provide a practical assessment of patients at risk, and outline an evidence-based approach to therapy for diabetic patients with foot ulcers. QUALITY OF EVIDENCE: A MEDLINE search was conducted for the period from 1979 to 1999 for articles relating to diabetic foot ulcers. Most studies found were case series or small controlled trials. MAIN MESSAGE: Foot ulcers in diabetic patients are common and frequently lead to lower limb amputation unless a prompt, rational, multidisciplinary approach to therapy is taken. Factors that affect development and healing of diabetic patients' foot ulcers include the degree of metabolic control, the presence of ischemia or infection, and continuing trauma to feet from excessive plantar pressure or poorly fitting shoes. Appropriate wound care for diabetic patients addresses these issues and provides optimal local ulcer therapy with débridement of necrotic tissue and provision of a moist wound-healing environment. Therapies that have no known therapeutic value, such as foot soaking and topical antiseptics, can actually be harmful and should be avoided. CONCLUSION: Family physicians are often primary medical contacts for patients with diabetes. Patients should be screened regularly for diabetic foot complications, and preventive measures should be initiated for those at risk of ulceration.
PMCID: PMC2018500  PMID: 11398715
11.  Negative Pressure Wound Therapy 
Executive Summary
Objective
This review was conducted to assess the effectiveness of negative pressure wound therapy.
Clinical Need: Target Population and Condition
Many wounds are difficult to heal, despite medical and nursing care. They may result from complications of an underlying disease, like diabetes; or from surgery, constant pressure, trauma, or burns. Chronic wounds are more often found in elderly people and in those with immunologic or chronic diseases. Chronic wounds may lead to impaired quality of life and functioning, to amputation, or even to death.
The prevalence of chronic ulcers is difficult to ascertain. It varies by condition and complications due to the condition that caused the ulcer. There are, however, some data on condition-specific prevalence rates; for example, of patients with diabetes, 15% are thought to have foot ulcers at some time during their lives. The approximate community care cost of treating leg ulcers in Canada, without reference to cause, has been estimated at upward of $100 million per year.
Surgically created wounds can also become chronic, especially if they become infected. For example, the reported incidence of sternal wound infections after median sternotomy is 1% to 5%. Abdominal surgery also creates large open wounds. Because it is sometimes necessary to leave these wounds open and allow them to heal on their own (secondary intention), some may become infected and be difficult to heal.
Yet, little is known about the wound healing process, and this makes treating wounds challenging. Many types of interventions are used to treat wounds.
Current best practice for the treatment of ulcers and other chronic wounds includes debridement (the removal of dead or contaminated tissue), which can be surgical, mechanical, or chemical; bacterial balance; and moisture balance. Treating the cause, ensuring good nutrition, and preventing primary infection also help wounds to heal. Saline or wet-to-moist dressings are reported as traditional or conventional therapy in the literature, although they typically are not the first line of treatment in Ontario. Modern moist interactive dressings are foams, calcium alginates, hydrogels, hydrocolloids, and films. Topical antibacterial agents—antiseptics, topical antibiotics, and newer antimicrobial dressings—are used to treat infection.
The Technology Being Reviewed
Negative pressure wound therapy is not a new concept in wound therapy. It is also called subatmospheric pressure therapy, vacuum sealing, vacuum pack therapy, and sealing aspirative therapy.
The aim of the procedure is to use negative pressure to create suction, which drains the wound of exudate (i.e., fluid, cells, and cellular waste that has escaped from blood vessels and seeped into tissue) and influences the shape and growth of the surface tissues in a way that helps healing. During the procedure, a piece of foam is placed over the wound, and a drain tube is placed over the foam. A large piece of transparent tape is placed over the whole area, including the healthy tissue, to secure the foam and drain the wound. The tube is connected to a vacuum source, and fluid is drawn from the wound through the foam into a disposable canister. Thus, the entire wound area is subjected to negative pressure. The device can be programmed to provide varying degrees of pressure either continuously or intermittently. It has an alarm to alert the provider or patient if the pressure seal breaks or the canister is full.
Negative pressure wound therapy may be used for patients with chronic and acute wounds; subacute wounds (dehisced incisions); chronic, diabetic wounds or pressure ulcers; meshed grafts (before and after); or flaps. It should not be used for patients with fistulae to organs/body cavities, necrotic tissue that has not been debrided, untreated osteomyelitis, wound malignancy, wounds that require hemostasis, or for patients who are taking anticoagulants.
Review Strategy
The inclusion criteria were as follows:
Randomized controlled trial (RCT) with a sample size of 20 or more
Human study
Published in English
Summary of Findings
Seven international health technology assessments on NPWT were identified. Included in this list of health technology assessments is the original health technology review on NPWT by the Medical Advisory Secretariat from 2004. The Medical Advisory Secretariat found that the health technology assessments consistently reported that NPWT may be useful for healing various types of wounds, but that its effectiveness could not be empirically quantified because the studies were poorly done, the patient populations and outcome measures could not be compared, and the sample sizes were small.
Six RCTs were identified that compared NPWT to standard care. Five of the 6 studies were of low or very low quality according to Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. The low and very low quality RCTs were flawed owing to small sample sizes, inconsistent reporting of results, and patients lost to follow-up. The highest quality study, which forms the basis of this health technology policy assessment, found that:
There was not a statistically significant difference (≥ 20%) between NPWT and standard care in the rate of complete wound closure in patients who had complete wound closure but did not undergo surgical wound closure (P = .15).
The authors of this study did not report the length of time to complete wound closure between NPWT and standard care in patients who had complete wound closure but who did not undergo surgical wound closure
There was no statistically significant difference (≥ 20%) in the rate of secondary amputations between the patients that received NPWT and those that had standard care (P = .06)
There may be an increased risk of wound infection in patients that receive NPWT compared with those that receive standard care.
Conclusion
Based on the evidence to date, the clinical effectiveness of NPWT to heal wounds is unclear. Furthermore, saline dressings are not standard practice in Ontario, thereby rendering the literature base irrelevant in an Ontario context. Nonetheless, despite the lack of methodologically sound studies, NPWT has diffused across Ontario.
Discussions with Ontario clinical experts have highlighted some deficiencies in the current approach to wound management, especially in the community. Because NPWT is readily available, easy to administer, and may save costs, compared with multiple daily conventional dressing changes, it may be used inappropriately. The discussion group highlighted the need to put in place a coordinated, multidisciplinary strategy for wound care in Ontario to ensure the best, continuous care of patients.
PMCID: PMC3379164  PMID: 23074484
12.  Effectiveness of bridge V.A.C. dressings in the treatment of diabetic foot ulcers 
Diabetic Foot & Ankle  2011;2:10.3402/dfa.v2i0.5893.
Objectives
This is a prospective study of the clinical efficacy of the V.A.C. Granufoam Bridge Dressing for the treatment of diabetic foot ulcers.
Materials and methods
Five consecutive patients with diabetic foot ulcers were treated with V.A.C. Granufoam Bridge Dressings and studied over a period of 22–48 days. The indications for treatment included diabetic patients with open ray amputation wounds and wounds post-drainage for abscess with exposed deep structures. Clinical outcome was measured in terms of reduction in wound dimensions, presence of wound granulation, microbial clearance, and development of wound complications.
Results
Our results showed that with V.A.C. therapy, wound healing occurred in all patients. The number of dressings required ranged from 8 to 10. The baseline average wound size was 23.1 cm2. Wound areas shrunk by 18.4–41.7%. All subjects achieved 100% wound bed granulation with an average length of treatment of 33 days. Microbial clearance was achieved in all cases. All wounds healed by secondary intention in one case and four cases required split-thickness skin grafting.
Conclusion
The V.A.C. Granufoam Bridge Dressing is effective in the treatment of diabetic foot ulcers. It promotes reduction of wound area, wound bed granulation, and microbial clearance. By allowing placement of the suction pad outside the foot, it allowed patients to wear protective shoes and to walk non-weight bearing with crutches during V.A.C. therapy.
doi:10.3402/dfa.v2i0.5893
PMCID: PMC3284286  PMID: 22396825
diabetic foot; negative pressure wound therapy; ulcer; neuropathy
13.  A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol 
Trials  2011;12:69.
Background
It has been suggested that the use of adjunctive hyperbaric oxygen therapy improves the healing of diabetic foot ulcers, and decreases the risk of lower extremity amputations. A limited number of studies have used a double blind approach to evaluate the efficacy of hyperbaric oxygen therapy in the treatment of diabetic ulcers. The primary aim of this study is to assess the efficacy of hyperbaric oxygen therapy plus standard wound care compared with standard wound care alone in preventing the need for major amputation in patients with diabetes mellitus and chronic ulcers of the lower limb.
Methods/Design
One hundred and eighteen (59 patients per arm) patients with non-healing diabetic ulcers of the lower limb, referred to the Judy Dan Research and Treatment Centre are being recruited if they are at least 18 years of age, have either Type 1 or 2 diabetes with a Wagner grading of foot lesions 2, 3 or 4 on lower limb not healing for at least 4 weeks. Patients receive hyperbaric oxygen therapy every day for 6 weeks during the treatment phase and are provided ongoing wound care and weekly assessments. Patients are required to return to the study centre every week for an additional 6 weeks of follow-up for wound evaluation and management. The primary outcome is freedom from having, or meeting the criteria for, a major amputation (below knee amputation, or metatarsal level) up to 12 weeks after randomization. The decision to amputate is made by a vascular surgeon. Other outcomes include wound healing, effectiveness, safety, healthcare resource utilization, quality of life, and cost-effectiveness. The study will run for a total of about 3 years.
Discussion
The results of this study will provide detailed information on the efficacy of hyperbaric oxygen therapy for the treatment of non-healing ulcers of the lower limb. This will be the first double-blind randomized controlled trial for this health technology which evaluates the efficacy of hyperbaric oxygen therapy in prevention of amputations in diabetic patients.
Trial registration
ClinicalTrials.gov Identifier: NCT00621608
doi:10.1186/1745-6215-12-69
PMCID: PMC3061927  PMID: 21385365
14.  Use of Pressure Offloading Devices in Diabetic Foot Ulcers 
Diabetes Care  2008;31(11):2118-2119.
OBJECTIVE—Pressure mitigation is crucial for the healing of plantar diabetic foot ulcers. We therefore discuss characteristics and considerations associated with the use of offloading devices.
RESEARCH DESIGN AND METHODS—A diabetic foot ulcer management survey was sent to foot clinics in all 50 states and the District of Columbia in 2005. A total of 901 geographically diverse centers responded. The survey recorded information regarding usage frequency and characteristics of assessment and treatment of diabetic foot ulcers in each center.
RESULTS—Of the 895 respondents who treat diabetic foot ulcers, shoe modifications (41.2%, P < 0.03) were the most common form of pressure mitigation, whereas total contact casts were used by only 1.7% of the centers.
CONCLUSIONS—This study reports the usage and characteristics of offloading devices in the care of diabetic foot ulcers in a broadly distributed geographic sample. Less than 2% of specialists use what has been termed the “gold standard” (total contact cast) for treating the majority of diabetic foot ulcers.
doi:10.2337/dc08-0771
PMCID: PMC2571059  PMID: 18694976
15.  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
16.  Is simulation training effective in increasing podiatrists' confidence in foot ulcer management? 
Background
Foot ulcers are a frequent reason for diabetes-related hospitalisation. Clinical training is known to have a beneficial impact on foot ulcer outcomes. Clinical training using simulation techniques has rarely been used in the management of diabetes-related foot complications or chronic wounds. Simulation can be defined as a device or environment that attempts to replicate the real world. The few non-web-based foot-related simulation courses have focused solely on training for a single skill or "part task" (for example, practicing ingrown toenail procedures on models). This pilot study aimed to primarily investigate the effect of a training program using multiple methods of simulation on participants' clinical confidence in the management of foot ulcers.
Methods
Sixteen podiatrists participated in a two-day Foot Ulcer Simulation Training (FUST) course. The course included pre-requisite web-based learning modules, practicing individual foot ulcer management part tasks (for example, debriding a model foot ulcer), and participating in replicated clinical consultation scenarios (for example, treating a standardised patient (actor) with a model foot ulcer). The primary outcome measure of the course was participants' pre- and post completion of confidence surveys, using a five-point Likert scale (1 = Unacceptable-5 = Proficient). Participants' knowledge, satisfaction and their perception of the relevance and fidelity (realism) of a range of course elements were also investigated. Parametric statistics were used to analyse the data. Pearson's r was used for correlation, ANOVA for testing the differences between groups, and a paired-sample t-test to determine the significance between pre- and post-workshop scores. A minimum significance level of p < 0.05 was used.
Results
An overall 42% improvement in clinical confidence was observed following completion of FUST (mean scores 3.10 compared to 4.40, p < 0.05). The lack of an overall significant change in knowledge scores reflected the participant populations' high baseline knowledge and pre-requisite completion of web-based modules. Satisfaction, relevance and fidelity of all course elements were rated highly.
Conclusions
This pilot study suggests simulation training programs can improve participants' clinical confidence in the management of foot ulcers. The approach has the potential to enhance clinical training in diabetes-related foot complications and chronic wounds in general.
doi:10.1186/1757-1146-4-16
PMCID: PMC3123628  PMID: 21639935
17.  Implementation of diabetic foot ulcer classification system for research purposes to predict lower extremity amputation 
BACKROUND:
Patients with diabetic foot ulcers are at a high risk of having both minor or major lower extremity amputations.
AIM:
To identify the extent of risk factors for major and minor amputations in patients with diabetic foot ulcers.
MATERIALS AND METHODS:
This prospective study was conducted from 2003 to 2005. Using the guidelines for wound classification developed by the International Consensus of the Diabetic Foot, patients were assessed for ischemia, neuropathy, linear measurement of wound diameters, depth of wound, and infection. In addition, end stage renal failure was added as a criterion to assess the association of all these criteria with both toe and lower extremity amputation.
RESULTS:
2,321 patients were studied and their mean age was 55 ± 12 years. Most (83.5%) of the patients presented with foot ulcers (n = 1394). Plantar ulcers were the most common (42.6%) followed by ulcers of the big toe (39%). Some (28.5%) of the patients had different types of amputations: 10% had major lower extreme amputation (MLEA) with 8.7% amputations being below the knee and minor (toe) amputations accounting for 18.5%. The most commonly amputated (9.9%) toe was the first toe.
CONCLUSION:
The guidelines for wound classification proposed by the International Consensus of the Diabetic Foot are reliable predictive factors and can determine the outcome of diabetic foot management. Significant factors associated with MLEA were ischemia, neuropathy, and end-stage renal disease and those associated with toe amputation were neuropathy, depth of wound, and grade of infection.
doi:10.4103/0973-3930.50707
PMCID: PMC2802358  PMID: 20062556
Amputation; diabetes; diabetic foot; ischemia; neuropathy
18.  Our Treatment Strategy for Critical Limb Ischemia 
For the treatment of critical limb ischemia, collaboration with wound specialists and cardiologists performing revascularization is important. The foot care unit affiliated with related departments opened at our hospital in July 2010 for limb salvage, mainly under the leadership of the departments of cardiovascular internal medicineand plastic surgery. We have treated 194 patients up until October 2012. The primary diseases included 81 cases (87 limbs) of foot ulcer and gangrene, with complications of peripheral arterial diseases (PADs) in all cases. Intravascular treatment was conducted for 69 limbs with PAD complications, and the initial success rate was 85.5%, of which surgical debridement or minor amputation was performed on 32 limbs. Regarding open wounds following operation and chronic ulcer, platelet-rich plasma therapy was conducted in 29 limbs and negative pressure wound therapy in 15 limbs. Among all of the patients treated, 58 limbs healed, 10 cases died, and the others are currently receiving ongoing treatment. Cardiovascular internal medicine specialists and plastic surgeons examine patients together at the outpatient clinic and prepare and implement a multidisciplinary treatment plan including vascular reconstructions and operation. We cooperate with physicians in each related department and efforts in team medicine have been made for the purpose of limb salvage.
doi:10.1155/2013/437471
PMCID: PMC3872428  PMID: 24386568
19.  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.
20.  The importance of growth factors for the treatment of chronic wounds in the case of diabetic foot ulcers 
Introduction
Ulcers as a result of diabetes mellitus are a serious problem with an enormous impact on the overall global disease burden due to the increasing prevalence of diabetes. Because of long hospital stays, rehabilitation, often required home care and the use of social services diabetic foot complications are costly. Therapy with growth factors could be an effective and innovative add-on to standard wound care.
Research questions
What is the benefit of therapies with growth factors alone or in combination with other technologies in the treatment of diabetic foot ulcer assessed regarding medical, economical, social, ethical and juridical aspects?
Methods
We systematically searched relevant databases limited to English and German language and publications since 1990. Cost values were adjusted to the price level of 2008 and converted into Euro. A review and an assessment of the quality of publications were conducted following approved methodical standards conforming to evidence-based medicine and health economics.
Results
We identified 25 studies (14 randomized controlled trials (RCT), nine cost-effectiveness analyses, two meta-analyses).
The RCT compared an add-on therapy to standard wound care with standard wound care/placebo alone or extracellular wound matrix: in six studies becaplermin, in two rhEGF, in one bFGF, and in five studies the metabolically active skin grafts Dermagraft and Apligraf.
The study duration ranged from twelve to 20 weeks and the study population included between 17 to 382 patients, average 130 patients.
The treatment with becaplermin, rhEGF and skin implants Dermagraft and Apligraf showed in eight out of 13 studies an advantage concerning complete wound closure and the time to complete wound healing. Evidence for a benefit of treatment with bFGF could not be found. In four out of 14 studies the proportion of adverse events was 30% per study group with no difference between the treatment groups. The methodological quality of the studies was affected by significant deficiencies.
The results showed becaplermin being cost-effective whereas no obvious statement can be made regarding Dermagraft and Apligraf because of diverging cost bases and incremental cost-effectiveness ratios.
Discussion
Differences in standard wound care are complicating the comparison of study results. Taking into consideration the small to very small sample sizes and other methodological flaws with high potential of bias, the validity of the results with regard to effectiveness and cost-effectiveness has to be considered limited. The duration of treatment and follow-up examinations is not long enough to assess the sustainability of the intervention and the surveillance of ulcer recurrences or treatment related adverse events like the development of malignancy.
Conclusions
There are indications of an advantage for the add-on therapy with growth factors in diabetic foot ulcers concerning complete wound closure and the time to complete wound healing. Further more studies of high methodological quality with adequate sample sizes and sufficient follow-up periods are necessary also investigating patient-relevant parameters like the health-related quality of life, the acceptance and tolerance of the intervention in addition to clinical outcomes.
doi:10.3205/hta000090
PMCID: PMC3010891  PMID: 21289885
diabetic foot; diabetes mellitus; diabetes mellitus type 01; diabetes mellitus type 02; diabetes mellitus, type 1; diabetes mellitus, type 2; diabetes mellitus, type I; diabetes mellitus, type II; diabetes related complications; wound healing; platelet activating factor; platelet-derived growth factor; recombinant proteins; controlled clinical trials, randomized; random allocation; review literature as topic; growth factor; therapy with growth factors; diabetes; foot ulcer; infection control; wound care; wound management; diabetic ulcer; diabetic foot ulcer; podology; hard healing wound; care; interdisciplinary team; efficiency; efficacy; cost-effectiveness; systematic review; HTA; Health Technology Assessment; health economics
21.  A Prospective Study of Negative Pressure Wound Therapy With Integrated Irrigation for the Treatment of Diabetic Foot Ulcers 
Eplasty  2011;11:e5.
Objective: Patients with diabetes often present with pedal wounds resistant to standard wound healing modalities and become chronic in nature. These chronic wounds in diabetic patients have a high incidence of complications including infection and amputation. Negative pressure wound therapy has been found to facilitate healing of the stagnant pedal wound. This protocol was designed to determine wound closure rates using a unique negative pressure wound therapy system that delivers vacuum-assisted wound closure with a simultaneous irrigation feature (Svedman Wound Treatment System). Methods: A prospective single center study was conducted in adults with diabetic foot ulcers ≥cm2 or more in size showing no signs of clinical infection, and having adequate blood flow. Patients received dressing changes and irrigation on a standard regimen with weekly wound assessments for a minimum of 6 weeks. Results: 11 women and 8 men with a mean wound size of 2.4 cm × 2.2 cm were treated with the device. A total of 14 of /19 (74%) patients healed completely, with a median healing time of 34 days (range, 9-114). Eleven of 19 patients (58%) healed within the 6-week evaluation period. For the 5 patients who did not heal completely with the device, other treatments were utilized, including further wound debridement, muscle flaps, and skin grafting procedures. Conclusions: Negative pressure wound therapy with integrated irrigation was well tolerated by the patients without complications related to the device application or irrigation feature. The data clearly suggests that this technology may be a promising alternative for the chronic nonhealing diabetic wound.
PMCID: PMC3041586  PMID: 21369361
22.  Lack of Effectiveness of Hyperbaric Oxygen Therapy for the Treatment of Diabetic Foot Ulcer and the Prevention of Amputation 
Diabetes Care  2013;36(7):1961-1966.
OBJECTIVE
Hyperbaric oxygen (HBO) is a device that is used to treat foot ulcers. The study goal was to compare the effectiveness of HBO with other conventional therapies administered in a wound care network for the treatment of a diabetic foot ulcer and prevention of lower-extremity amputation.
RESEARCH DESIGN AND METHODS
This was a longitudinal observational cohort study. To address treatment selection bias, we used propensity scores to determine the “propensity” that an individual was selected to receive HBO.
RESULTS
We studied 6,259 individuals with diabetes, adequate lower limb arterial perfusion, and foot ulcer extending through the dermis, representing 767,060 person-days of wound care. In the propensity score–adjusted models, individuals receiving HBO were less likely to have healing of their foot ulcer (hazard ratio 0.68 [95% CI 0.63–0.73]) and more likely to have an amputation (2.37 [1.84–3.04]). Additional analyses, including the use of an instrumental variable, were conducted to assess the robustness of our results to unmeasured confounding. HBO was not found to improve the likelihood that a wound might heal or to decrease the likelihood of amputation in any of these analyses.
CONCLUSIONS
Use of HBO neither improved the likelihood that a wound would heal nor prevented amputation in a cohort of patients defined by Centers for Medicare and Medicaid Services eligibility criteria. The usefulness of HBO in the treatment of diabetic foot ulcers needs to be reevaluated.
doi:10.2337/dc12-2160
PMCID: PMC3687310  PMID: 23423696
23.  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
24.  Clinical Implications of Diabetes on the Foot 
Journal of Athletic Training  1997;32(1):55-58.
Objective:
Athletic trainers must understand the clinical implications of diabetes on the athletic foot in order to promote proper foot care and footwear and to adapt protocols for treatment and exercise of the affected athlete.
Data Sources:
The MEDLINE and CINAHL databases were searched for the years 1984 to 1996 with the terms “diabetes and foot,” “neuropathy,” and “Charcot joint.”
Data Synthesis:
As more athletes with diabetes participate in sports, athletic trainers must develop the skills and knowledge necessary to manage this metabolic illness. Although the need to keep blood glucose levels carefully controlled is well known, the impact of diabetes on the foot is not as well recognized. Peripheral vascular disease, soft tissue neuropathy, and neuropathic arthropathy are the most common complications of diabetes affecting the foot. However, with proper management, these complications can be minimized, allowing diabetic athletes and nonathletes to lead more normal and functional lives.
Conclusions/Recommendations:
The athletic trainer can assist the diabetic athlete by promoting proper foot care and footwear and adapting protocols for treatment and exercise.
PMCID: PMC1319237  PMID: 16558434
peripheral vascular disease; neuropathy; neuropathic arthropathy
25.  Foot Care Knowledge and Practices and the Prevalence of Peripheral Neuropathy Among People with Diabetes Attending a Secondary Care Rural Hospital in Southern India 
Background:
Diabetes mellitus is a multifaceted disease and foot ulceration is one of its most common complications. Poor foot care knowledge and practices are important risk factors for foot problems among people with diabetes.
Aims:
To assess the knowledge and practices regarding foot care and to estimate the proportion of people with peripheral neuropathy among people with diabetes.
Settings and Design:
The cross-sectional study was conducted in 212 consecutive diabetes patients attending the out-patient department of a rural secondary care hospital.
Materials and Methods:
A questionnaire which included demographic details, knowledge questionnaire, and Nottingham assessment of functional foot care was administered. The Michigan Neuropathy Screening Instrument was used to identify peripheral neuropathy.
Statistical Analysis Used:
Descriptive analysis with frequency distribution for knowledge and practice scores, univariate analysis, and multiple logistic regressions to find significant variables associated with good knowledge and practice scores.
Results:
About 75% had good knowledge score and 67% had good foot care practice score. Male gender (OR 2.36, 95% CI 1.16–4.79), poor education status (OR 2.40, 95% CI 1.19–4.28), and lesser duration of diabetes (OR 2.24, 95% CI 1.15–4.41) were significantly associated with poor knowledge on foot care. Poor knowledge was associated with poor foot care practices (OR 3.43, 95% CI 1.75–6.72). The prevalence of neuropathy was 47% (95% CI 40.14–53.85) and it was associated with longer duration of the disease (OR 2.18, 95% CI 1.18–4.04).
Conclusion:
There exist deficiencies in knowledge and practices regarding foot care. Male gender, low education, and lesser duration of diabetes are associated with poor knowledge scores. The prevalence of diabetic peripheral neuropathy is high.
doi:10.4103/2249-4863.109938
PMCID: PMC3894008  PMID: 24479039
Diabetes; foot care; knowledge; neuropathy; practices

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