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

Indra B Napit, Dilip Shrestha, Jon Bishop, Sopna Choudhury, Santosh Dulal, Paramjit Gill, Eleni Gkini, Holly Gwyther, Deanna A Hagge, Karuna Neupane, Jo Sartori, Gemma Slinn, Samuel I Watson, Richard Lilford

Research output: Contribution to journalArticlepeer-review

116 Downloads (Pure)

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.gov ISRCTN14933421 . Registered on 16 June 2020.

Original languageEnglish
Article number453
JournalTrials
Volume22
Issue number1
DOIs
Publication statusPublished - 15 Jul 2021

Bibliographical note

© 2021. The Author(s).

Keywords

  • Adolescent
  • Adult
  • Drug Therapy, Combination
  • Humans
  • Leprostatic Agents
  • Leprosy/diagnosis
  • Leukocytes
  • Nepal
  • Platelet-Rich Fibrin
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Ulcer

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this