The Library
An individual randomised efficacy trial of autologous blood products, leukocyte and platelet-rich fibrin (L-PRF), to promote ulcer healing in leprosy in Nepal : the TABLE trial protocol
Tools
Tools
Tools
Napit, Indra B., Shrestha, Dilip, Bishop, Jon, Choudhury, Sopna, Dulal, Santosh, Gill, Paramjit, Gkini, Eleni, Gwyther, Holly, Hagge, Deanna A., Neupane, Karuna, Sartori, Jo, Slinn, Gemma, Watson, Samuel I. and Lilford, Richard (2021) An individual randomised efficacy trial of autologous blood products, leukocyte and platelet-rich fibrin (L-PRF), to promote ulcer healing in leprosy in Nepal : the TABLE trial protocol. Trials, 22 (1). 453. doi:10.1186/s13063-021-05392-5 ISSN 1745-6215.
|
PDF
WRAP-individual-randomised-efficacy-trial-autologous-blood-products-leukocyte-platelet-rich-Gill-2021.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1443Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/s13063-021-05392-5
Abstract
Background:
Leprosy is curable with multidrug therapy and treatment in the early stages can prevent disability. However, local nerve damage can lead to injury and consequently recurring and disfiguring ulcers. The aim of this study is to evaluate the treatment of leprosy ulcers using an autologous blood product; leukocyte and platelet-rich fibrin (L-PRF) to promote healing.
Methods:
This is a single-centre study in the Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal. Consenting patients (n=130) will be individually randomised in a single-blinded, controlled trial. Participants will be 18 years of age or older, admitted to the hospital with a clean, dry and infection-free chronic foot ulcer between 2 and 20 cm2 in size. If the ulcer is infected, it will be treated before enrolment into the study. The intervention involves the application of leukocyte and platelet-rich fibrin (L-PRF) matrix on the ulcer beds during twice-weekly dressing changes. Controls receive usual care in the form of saline dressings only during their twice-weekly dressing changes. Primary outcomes are the rate of healing assessed using standardised photographs by observers blind to allocated treatment, and time to complete re-epithelialization. Follow-up is at 6 months from randomisation.
Discussion:
This research will provide valuable information on the clinical and cost-effectiveness of L-PRF in the treatment of leprosy ulcers. An additional benefit is the evaluation of the effects of treatment on quality of life for people living with leprosy ulcers. The results will improve our understanding of the scalability of this treatment across low-income countries for ulcer healing in leprosy and potentially other conditions such as diabetic ulcers.
Trial registration:
ClinicalTrials.govISRCTN14933421. Registered on 16 June 2020
| Item Type: | Journal Article | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Subjects: | Q Science > QR Microbiology R Medicine > RA Public aspects of medicine |
|||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
|||||||||
| Library of Congress Subject Headings (LCSH): | Leprosy -- Nepal, Blood platelets, Mycobacterium leprae, Clinical trials -- Nepal | |||||||||
| Journal or Publication Title: | Trials | |||||||||
| Publisher: | Biomed Central | |||||||||
| ISSN: | 1745-6215 | |||||||||
| Official Date: | 15 July 2021 | |||||||||
| Dates: |
|
|||||||||
| Volume: | 22 | |||||||||
| Number: | 1 | |||||||||
| Article Number: | 453 | |||||||||
| DOI: | 10.1186/s13063-021-05392-5 | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Access rights to Published version: | Open Access (Creative Commons) | |||||||||
| Date of first compliant deposit: | 20 July 2021 | |||||||||
| Date of first compliant Open Access: | 21 July 2021 | |||||||||
| RIOXX Funder/Project Grant: |
|
|||||||||
| Is Part Of: | 1 |
Request changes or add full text files to a record
Repository staff actions (login required)
 |
View Item |
Downloads
Downloads per month over past year
