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

Abstract

BackgroundDiabetic foot ulcers are a common and severe complication of diabetes mellitus. Standard treatment includes debridement, offloading, management of infection and revascularisation where appropriate, although healing times may be long. The LeucoPatch® device is used to generate an autologous platelet-rich fibrin and leucocyte wound dressing produced from the patient’s own venous blood by centrifugation, but without the addition of any reagents. The final product comprises a thin, circular patch composed predominantly of fibrin together with living platelets and leucocytes. Promising results have been obtained in non-controlled studies this system, but this now needs to be tested in a randomised controlled trial (RCT). If confirmed, the LeucoPatch® may become an important new tool in the armamentarium in the management of diabetic foot ulcers which are hard-to-heal.MethodsPeople with diabetes and hard-to-heal ulcers of the foot will receive either pre-specified good standard care or good standard care supplemented by the application of the LeucoPatch® device.The primary outcome will be the percentage of ulcers healed within 20 weeks. Healing will be defined as complete epithelialisation without discharge that is maintained for 4 weeks and is confirmed by an observer blind to randomisation group.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.

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: a systematic review

“…Following their introduction, more studies have been published with detailed study methodologies, independent randomization, blinding, and standardization of usual care in multicentre studies. 38,161,180,235 This is encouraging and supports the long-held notion that the delivery of high-quality studies in this field is indeed feasible. 236 Despite this, the majority of the new articles reviewed was still at a moderate to high risk of bias.…”

“…The 21‐point assessment criteria developed jointly by the IWGDF and the European Wound Management Association to guide improvements in trial design and presentation of study findings were published in 2016. Following their introduction, more studies have been published with detailed study methodologies, independent randomization, blinding, and standardization of usual care in multicentre studies . This is encouraging and supports the long‐held notion that the delivery of high‐quality studies in this field is indeed feasible .…”

“…The efficacy of sucrose octasulfate impregnated dressings and the autologous combined leucocytes, platelets, and fibrin patch has been shown in large, well‐conducted randomized trials, both at low risk of bias. The choice of ulcers included was different although neither included infected ulcers at randomization.…”

Advanced hydrogels for treatment of diabetes

“…This was followed by an open multicentre clinical study of 41 patients with hard to heal DFU treated weekly with Leucopatch that showed 32% healing within 12 weeks and 54% within 20 weeks (Londahl et al, 2015). Currently, a recent randomized controlled clinical trial is running in the United Kingdom, Denmark, and Sweden on 269 patients with hard to heal DFU with the primary outcome set as percentage of ulcers healed within 20 weeks (Game et al, 2017). The outcome of this crucial study has yet to be reported.…”

Editorial and Mini-Review: Topical Oxygen Therapy for Diabetic Foot Ulcerations - Avenue Towards New Hope?

“…Indeed, according to the United Kingdom National Diabetic Foot Audit, less than half of all new diabetic foot ulcers are healed by 12 weeks [4]. Even in specialized centers, healing rates for DFUs amount to 22-30% at 20 weeks [5,6].…”