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
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 auto...
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doaj-eda7dfb319ae4168a6e1ec55aeda2b1d2021-07-18T11:38:12ZengBMCTrials1745-62152021-07-0122111310.1186/s13063-021-05392-5An 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 protocolIndra B. Napit0Dilip Shrestha1Jon Bishop2Sopna Choudhury3Santosh Dulal4Paramjit Gill5Eleni Gkini6Holly Gwyther7Deanna A. Hagge8Karuna Neupane9Jo Sartori10Gemma Slinn11Samuel I. Watson12Richard Lilford13Anandaban Hospital, The Leprosy Mission NepalAnandaban Hospital, The Leprosy Mission NepalBirmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of BirminghamInstitute of Applied Health Research, College of Medical and Dental Sciences, University of BirminghamAnandaban Hospital, The Leprosy Mission NepalDivision of Health Sciences, Warwick Medical School, University of WarwickBirmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of BirminghamInstitute of Applied Health Research, College of Medical and Dental Sciences, University of BirminghamAnandaban Hospital, The Leprosy Mission NepalAnandaban Hospital, The Leprosy Mission NepalInstitute of Applied Health Research, College of Medical and Dental Sciences, University of BirminghamBirmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of BirminghamInstitute of Applied Health Research, College of Medical and Dental Sciences, University of BirminghamInstitute of Applied Health Research, College of Medical and Dental Sciences, University of BirminghamAbstract 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 2020https://doi.org/10.1186/s13063-021-05392-5LeprosyMycobacterium lepraeUlcerL-PRFNepalWound |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 |
spellingShingle |
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 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 Leprosy Mycobacterium leprae Ulcer L-PRF Nepal Wound |
author_facet |
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 |
author_sort |
Indra B. Napit |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2021-07-01 |
description |
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 |
topic |
Leprosy Mycobacterium leprae Ulcer L-PRF Nepal Wound |
url |
https://doi.org/10.1186/s13063-021-05392-5 |
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