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1.  Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial 
Trials  2014;15:462.
Ulcers of the heel in diabetes are the source of considerable suffering and cost. In the absence of specific treatments, it has been suggested that removable, lightweight fibreglass heel casts may both promote healing and reduce discomfort and pain. The aim of the study is to assess the effectiveness and cost-effectiveness of fibreglass heel casts in the management of heel ulcers.
This is an observer-blind, randomised controlled trial in which participants with diabetes and heel ulcers (NPUAP/EPUAP grades 2, 3 or 4 and present for 2 or more weeks) are randomised to receive either usual care plus lightweight fibreglass heel casts or usual care alone. Randomisation is undertaken by random number sequence generation incorporated as part of the electronic case record form, and is stratified by both ulcer area (less than versus equal to or greater than 1 cm2) and NPUAP/EPUAP grade. Participants are followed every two weeks until healing or for 24 weeks. The primary outcome measure is healing at or before 24 weeks and maintained for 4 weeks. Secondary outcomes include (i) ulcer-related outcomes: time to healing, change in ulcer area, minor and major amputation, secondary infection and (ii) patient-related outcomes: local pain, mood and function (EQ-5D), impact of the ulcer (Cardiff Wound Impact Schedule) and survival. Cost-effectiveness will be assessed using a decision analytic model to estimate costs from the perspective of the UK NHS and personal social services and health outcomes, including percent healing and Quality Adjusted Life Years gained.
Safety will be documented as adverse and serious adverse device effects.
If it is possible to confirm significant clinical benefit and/or cost-effectiveness, this would have direct implications for the management of this distressing and costly complication of diabetes
Trial registration number
ISRCTN62524796 Registered 29 March 2011
PMCID: PMC4289201  PMID: 25428268
Diabetic foot ulcer; Heel; Pressure sore; Ulcer healing; Diabetes complications; Neuropathy; Casting; Off-loading; Amputation
3.  Does the Diabetic Foot Have a Significant Impact on Selected Psychological or Social Characteristics of Patients with Diabetes Mellitus? 
Journal of Diabetes Research  2014;2014:371938.
The aim of our case-control study was to compare selected psychological and social characteristics between diabetic patients with and without the DF (controls). Methods. 104 patients with and 48 without DF were included into our study. Both study groups were compared in terms of selected psychosocial characteristics. Results. Compared to controls, patients with DF had a significantly worse quality of life in the area of health and standard of living as shown by lower physical health domain (12.7 ± 2.8 versus 14.7 ± 2.5; P < 0.001) and environment domain (14.1 ± 2.2 versus 15 ± 1.8; P < 0.01) that negatively correlated with diabetes duration (r = −0.061; P = 0.003). Patients with DF subjectively felt more depressed in contrast to controls (24.5 versus 7.3%; P < 0.05); however, the depressive tuning was objectively proven in higher percentage in both study groups (83.2 versus 89.6; NS). We observed a significantly lower level of achieved education (P < 0.01), more patients with disability pensions (P < 0.01), and low self-support (P < 0.001) in patients with the DF compared to controls. In the subgroup of patients with a previous major amputation and DF (n = 6), there were significantly worse outcomes as in the environment domain (P < 0.01), employment status, and stress readaptation (P < 0.01) in contrast to the main study groups. Conclusions. Patients with DF had a predominantly worse standard of living. In contrast to our expectations, patients with DF appeared to have good stress tolerability and mental health (with the exception of patients with previous major amputation) and did not reveal severe forms of depression or any associated consequences.
PMCID: PMC3984852  PMID: 24791012
4.  The Charcot Foot in Diabetes 
Diabetes Care  2011;34(9):2123-2129.
The diabetic Charcot foot syndrome is a serious and potentially limb-threatening lower-extremity complication of diabetes. First described in 1883, this enigmatic condition continues to challenge even the most experienced practitioners. Now considered an inflammatory syndrome, the diabetic Charcot foot is characterized by varying degrees of bone and joint disorganization secondary to underlying neuropathy, trauma, and perturbations of bone metabolism. An international task force of experts was convened by the American Diabetes Association and the American Podiatric Medical Association in January 2011 to summarize available evidence on the pathophysiology, natural history, presentations, and treatment recommendations for this entity.
PMCID: PMC3161273  PMID: 21868781

Results 1-4 (4)