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

Santosh Dulal¹  Indra B. Napit¹  Deanna A. Hagge¹  Dilip Shrestha¹  Karuna Neupane¹  Jon Bishop²  Gemma Slinn²  Eleni Gkini²  Paramjit Gill³  Samuel I. Watson⁴  Holly Gwyther⁴  Sopna Choudhury⁴  Richard Lilford⁴  Jo Sartori⁴ 

[1] Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal;Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, B15 2TT, Birmingham, UK;Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK;Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, B15 2TT, Birmingham, UK;

关键词: Leprosy;    Mycobacterium leprae;    Ulcer;    L-PRF;    Nepal;    Wound;   

DOI  :  10.1186/s13063-021-05392-5

来源: Springer

【 摘 要 】

BackgroundLeprosy 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.MethodsThis 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.DiscussionThis 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 registrationISRCTN14933421. Registered on 16 June 2020

【 授权许可】

CC BY