LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers
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|ClinicalTrials.gov Identifier: NCT02224742|
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : June 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Device: LeucoPatch Other: Usual care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||269 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||May 2018|
Usual care supplemented by the application of LeucoPatch centrifugates that comprise autologous fibrin patches containing living white cells and platelets
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.
Active Comparator: Usual care
Usual care provided in a multidisciplinary foot care clinic, in accordance with international guidelines
Other: Usual care
Usual wound care provided in a multidisciplinary foot care clinic , in accordance with international guidelines.
Components of usual wound care include:
- Healing [ Time Frame: Within 20 weeks of randomisation ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224742
|Principal Investigator:||Frances Game, FRCP||University Hospitals of Derby and Burton NHS Foundation Trust|