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.

Autor: Napit IB; Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal. indran@TLMnepal.org., Shrestha D; Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal., Bishop J; Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK., Choudhury S; Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK., Dulal S; Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal., Gill P; Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK., Gkini E; Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK., Gwyther H; Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK., Hagge DA; Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal., Neupane K; Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal., Sartori J; Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK., Slinn G; Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK., Watson SI; Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK., Lilford R; Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Jazyk: angličtina
Zdroj: Trials [Trials] 2021 Jul 15; Vol. 22 (1), pp. 453. Date of Electronic Publication: 2021 Jul 15.
DOI: 10.1186/s13063-021-05392-5
Abstrakt: 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 cm 2 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.gov ISRCTN14933421 . Registered on 16 June 2020.
(© 2021. The Author(s).)
Databáze: MEDLINE
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