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

Game, Frances; Jeffcoate, William; Tarnow, Lise; Day, Florence; Fitzsimmons, Deborah and Jacobsen, Judith (2017) In Trials 18(1).
Abstract

Background: Diabetic 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... (More)

Background: Diabetic 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. Methods: People 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. Discussion: Ulcers 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 registration: International Standard Randomised Controlled Trial, ISRCTN27665670. Registered on 5 July 2013.

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author
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Amputation, Diabetes complications, Diabetic foot ulcer, Platelets, Ulcer healing
in
Trials
volume
18
issue
1
publisher
BioMed Central
external identifiers
  • scopus:85030836277
ISSN
1745-6215
DOI
10.1186/s13063-017-2216-9
language
English
LU publication?
no
id
c2acd91e-b785-4503-b133-2729c7a82636
date added to LUP
2017-11-02 11:02:34
date last changed
2018-01-07 12:24:34
@article{c2acd91e-b785-4503-b133-2729c7a82636,
  abstract     = {<p>Background: Diabetic 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. Methods: People 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. Discussion: Ulcers 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 registration: International Standard Randomised Controlled Trial, ISRCTN27665670. Registered on 5 July 2013.</p>},
  articleno    = {469},
  author       = {Game, Frances and Jeffcoate, William and Tarnow, Lise and Day, Florence and Fitzsimmons, Deborah and Jacobsen, Judith},
  issn         = {1745-6215},
  keyword      = {Amputation,Diabetes complications,Diabetic foot ulcer,Platelets,Ulcer healing},
  language     = {eng},
  month        = {10},
  number       = {1},
  publisher    = {BioMed Central},
  series       = {Trials},
  title        = {The LeucoPatch® system in the management of hard-to-heal diabetic foot ulcers : Study protocol for a randomised controlled trial},
  url          = {http://dx.doi.org/10.1186/s13063-017-2216-9},
  volume       = {18},
  year         = {2017},
}