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.
L-PRF
Leprosy
Mycobacterium leprae
Nepal
Ulcer
Wound
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
15 Jul 2021
15 Jul 2021
Historique:
received:
22
02
2021
accepted:
23
06
2021
entrez:
16
7
2021
pubmed:
17
7
2021
medline:
20
7
2021
Statut:
epublish
Résumé
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. 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 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. ClinicalTrials.gov ISRCTN14933421 . Registered on 16 June 2020.
Sections du résumé
BACKGROUND
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
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
DISCUSSION
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov ISRCTN14933421 . Registered on 16 June 2020.
Identifiants
pubmed: 34266456
doi: 10.1186/s13063-021-05392-5
pii: 10.1186/s13063-021-05392-5
pmc: PMC8281567
doi:
Substances chimiques
Leprostatic Agents
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
453Subventions
Organisme : Medical Research Council
ID : MR/V038591/1
Pays : United Kingdom
Organisme : National Institute for Health Research
ID : NIHR: 200132
Informations de copyright
© 2021. The Author(s).
Références
Rodrigues LC, Lockwood DNJ. Leprosy now: epidemiology, progress, challenges, and research gaps. Lancet Infect Dis. 2011;11(6):464–70. https://doi.org/10.1016/S1473-3099(11)70006-8 .
doi: 10.1016/S1473-3099(11)70006-8
pubmed: 21616456
Scollard DM, Adam LB, Gillis TP, Krahenbuhl JL, Truman RW, Williams DL. The continuing challenges of leprosy. Clin Microbiol Rev. 2006;19(2):338–81. https://doi.org/10.1128/CMR.19.2.338-381.2006 .
doi: 10.1128/CMR.19.2.338-381.2006
pubmed: 16614253
pmcid: 1471987
Wellington T, Schofield C. Late-onset ulnar neuritis following treatment of lepromatous leprosy infection. PLoS Negl Trop Dis. 2019;13(8):e0007684. https://doi.org/10.1371/journal.pntd.0007684 .
doi: 10.1371/journal.pntd.0007684
pubmed: 31425515
pmcid: 6715229
World Health Organisation. Global leprosy update, 2018: moving towards a leprosy-free world. Wkly Epidemiol Rec. 2019;94(35/36):389–412.
The Leprosy Mission International. Nepal. 2019. Available from: https://www.leprosymission.org/tlm-in-your-country/nepal . Accessed 3 Feb 2020.
Apelqvist J. Diagnostics and treatment of the diabetic foot. Endocrine. 2012;41(3):384–97. https://doi.org/10.1007/s12020-012-9619-x .
doi: 10.1007/s12020-012-9619-x
pubmed: 22367583
Alem A. Prevalence of mental distress in the outpatient clinic of a specialized leprosy hospital. Addis Ababa, Ethiopia, 2002. Lepr Rev. 2004;75:367–75.
doi: 10.47276/lr.75.4.367
Reinar LM, Forsetlund L, Lehman LF, Brurberg KG. Interventions for ulceration and other skin changes caused by nerve damage in leprosy. Cochrane Database Syst Rev. 2019;7(7):CD012235.
pubmed: 31425632
Lambert SM, Walker SL, Harnisch JP. Chapter 40 - Leprosy (Hansen’s Disease). In: Sanford CA, Pottinger PS, Jong EC, editors. The Travel and Tropical Medicine Manual. 5th ed. New York: Elsevier; 2017. p. 513–23.
Reinar LM, Forsetlund L, Bjørndal A, Lockwood D. Interventions for skin changes caused by nerve damage in leprosy. Cochrane Database Syst Rev. 2008;(3):CD004833. https://doi.org/10.1002/14651858.CD004833.pub3 . Update in: Cochrane Database Syst Rev. 2019;8:CD004833.
Driver VR, Hanft J, Fylling CP, Beriou JM. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Ostomy Wound Manage. 2006;52(6):68–70, 2, 4 passim.
pubmed: 16799184
Martinez-Zapata MJ, Martí-Carvajal AJ, Solà I, Expósito JA, Bolíbar I, Rodríguez L, Garcia J, Zaror C. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev. 2016;(5):CD006899. https://doi.org/10.1002/14651858.CD006899.pub3 .
Keene DJ, Alsousou J, Willett K. How effective are platelet rich plasma injections in treating musculoskeletal soft tissue injuries? BMJ. 2016;352:i517.
doi: 10.1136/bmj.i517
Pinto NR, Ubilla M, Zamora Y, Del Rio V, Dohan Ehrenfest DM, Quirynen M. Leucocyte- and platelet-rich fibrin (L-PRF) as a regenerative medicine strategy for the treatment of refractory leg ulcers: a prospective cohort study. Platelets. 2018;29(5):468–75. https://doi.org/10.1080/09537104.2017.1327654 .
doi: 10.1080/09537104.2017.1327654
pubmed: 28727481
World Health Organisation. Process of translation and adaption of instruments. 2019. Available from: https://www.who.int/substance_abuse/research_tools/translation/en/ .
Keshavamurthy V, Sawatkar G, Dogra S, Narang T. Platelet rich fibrin dressings in the treatment of non-healing trophic ulcers of leprosy. Lepr Rev. 2018;89:158–64.
doi: 10.47276/lr.89.2.158
Samir K. Lung health in Rural Nepal. Groningen: University of Groningen; 2005.
Kularatna S, Whitty JA, Johnson NW, Jayasinghe R, Scuffham PA. Valuing EQ-5D health states for Sri Lanka. Qual Life Res. 2015;24(7):1785–93. https://doi.org/10.1007/s11136-014-0906-2 .
doi: 10.1007/s11136-014-0906-2
pubmed: 25543271
Liu GG, Wu H, Li M, Gao C, Luo N. Chinese time trade-off values for EQ-5D health states. Value Health. 2014;17(5):597–604. https://doi.org/10.1016/j.jval.2014.05.007 .
doi: 10.1016/j.jval.2014.05.007
pubmed: 25128053
Zhuo L, Xu L, Ye J, Sun S, Zhang Y, Burstrom K, et al. Time Trade-off value set for EQ-5D-3L Based on a nationally representative Chinese Population Survey. Value Health. 2018;21(11):1330–7. https://doi.org/10.1016/j.jval.2018.04.1370 .
doi: 10.1016/j.jval.2018.04.1370
pubmed: 30442281
Birke JA, Novick A, Patout CA, Coleman WC. Healing rates of plantar ulcers in leprosy and diabetes. Lepr Rev. 1992;63(4):365–74. https://doi.org/10.5935/0305-7518.19920044 .
doi: 10.5935/0305-7518.19920044
pubmed: 1479877
Rosenberger WF, Lachin JM. Randomization in clinical trials: theory and practice. New York: Wiley; 2015.
Bowen AC, Burns K, Tong SYC, Andrews RM, Liddle R, Irene MO, et al. Standardising and assessing digital images for use in clinical trials: a practical, reproducible method that blinds the assessor to treatment allocation. PLoS One. 2014;9(11):e110395. https://doi.org/10.1371/journal.pone.0110395 .
doi: 10.1371/journal.pone.0110395
pubmed: 25375169
pmcid: 4222834
Wendelken ME, Berg WT, Lichtenstein P, Markowitz L, Comfort C, Alvarez OM. Wounds measured from digital photographs using photodigital planimetry software: validation and rater reliability. Wounds. 2011;23(9):267–75.
pubmed: 25879267
Romano JP, Wolf M. Exact and approximate stepdown methods for multiple hypothesis testing. J Am Stat Assoc. 2005;100(469):94–108. https://doi.org/10.1198/016214504000000539 .
doi: 10.1198/016214504000000539
Thompson J, Davey C, Hayes R, Hargreaves J, Fielding K. Permutation tests for stepped-wedge cluster-randomized trials. Stata J. 2019;19(4):803–19. https://doi.org/10.1177/1536867X19893624 .
doi: 10.1177/1536867X19893624
pubmed: 32565746
pmcid: 7305031
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8(1):18. https://doi.org/10.1186/1741-7015-8-18 .
doi: 10.1186/1741-7015-8-18
pubmed: 20334633
pmcid: 2860339
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340(mar23 1):c869. https://doi.org/10.1136/bmj.c869 .
doi: 10.1136/bmj.c869
pubmed: 20332511
pmcid: 2844943