title: Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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 cm(2)) 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.
  
  
  CONCLUSIONS
  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
  
  
  BACKGROUND
  ISRCTN62524796 Registered 29 March 2011.
authors.affiliation: Foot Ulcer Trials Unit, Department of Diabetes and Endocrinology, Nottingham University Hospitals NHS Trust, City Hospital Campus, Hucknall Road, Nottingham, NG5 1 PB, UK. wjeffcoate@futu.co.uk.
authors.forename: William
authors.initials: W
authors.lastname: Jeffcoate
authors.forename: Frances
authors.initials: F
authors.lastname: Game
authors.forename: Patricia
authors.initials: P
authors.lastname: Price
authors.forename: Ceri
authors.initials: C
authors.lastname: Phillips
authors.forename: Vivienne
authors.initials: V
authors.lastname: Turtle-Savage
mesh_terms: D000339:Affect; D000671:Amputation, Surgical; D002370:Casts, Surgical / Q000191:economics; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D017719:Diabetic Foot / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D017048:Health Care Costs; D006801:Humans; D023821:Limb Salvage; D010147:Pain Measurement; D019057:Quality-Adjusted Life Years; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing; D014946:Wound Infection / Q000382:microbiology