The LeucoPatch ® system in the management of hard-to-heal diabetic foot ulcers: study protocol for a randomised controlled trial

DiscussionUlcers of the foot are a major source of morbidity to patients with diabetes and costs to health care economies. The study population is designed to be as inclusive as possible with the aim of maximising the external validity of any findings. The primary outcome measure is healing within 20  weeks of randomisation and the trial also includes a number of secondary outcome measures. Among these are rate of change in ulcer area as a predictor of the likelihood of eventual healing, minor and major amputation of the target limb, the incidence of infection and quality of life.Trial registrationInternational Standard Randomised Controlled Trial,ISRCTN27665670. Registered on 5 July 2013.
Source: Trials - Category: Research Source Type: clinical trials