NCT02224742

LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Nottingham University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Diabetic foot ulcers are the source of considerable suffering and cost and there are currently no wound care products available that have been demonstrated to improve healing, or that are cost effective. There have however been a small number of studies which have examined the use of platelets or fluid derived from platelets, either from the patient's own blood or from blood bank products. These have suggested some promise, but have suffered from technical difficulties in making a suitable wound care product or the volume of blood required to derive the product. It is thought that the reason why they may work is that growth factors released by the platelets may stimulate the wound to heal. This study will be a formal, randomised controlled trial to assess a new device for creating a wound care product which is a plug or patch comprising fibrin, white cells and platelets derived from 18 mls of the patients own blood. The application of this fibrin/white cell/platelet patch to the patients wound on a weekly basis will be compared with usual best care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25 centres in the United Kingdom, Denmark and Sweden.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	LeucoPatch	LeucoPatch® is prepared by centrifuging one or more 18mL aliquots of the participant's venous blood in the LeucoPatch device and bench-top centrifuge. The centrifugation yields a tough layer of fibrin, with viable white cells and platelets, and this is applied directly to the wound surface using sterile forceps. The wound is then covered with an inert primary dressing, secondary protective dressing and the ulcerated area protected with appropriate off-loading. The patch is prepared and applied each week for up to 20 weeks or until the wound is judged healed.
OTHER	Usual care	Usual wound care provided in a multidisciplinary foot care clinic , in accordance with international guidelines. Components of usual wound care include: * Formal assessment of ulcer and surrounding skin * Provision of any necessary off-loading * Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) * Appropriate dressing products * Appropriate antibiotic therapy * Nutrition and self care * Optimal glycaemic control * Revascularisation if deemed clinically necessary * Continued close observation

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-10-01
• Completion: 2018-05-01
• First posted: 2014-08-25
• Last updated: 2018-06-25

Locations

32 sites across 3 countries: Denmark, Sweden, United Kingdom