Evidence map›Paper›PMID 34266456›Full record

ArticleTrials2021

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 and 4 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.5field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 10 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 3 institutions in 2 countries.

Indra B NapitAnandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal. indran@TLMnepal.org.ORCID http://orcid.org/0000-0003-0622-880X
Dilip ShresthaAnandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal.
Jon BishopBirmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Sopna ChoudhuryInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Santosh DulalAnandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal.
Paramjit GillDivision of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
Eleni GkiniBirmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Holly GwytherInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Deanna A HaggeAnandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal.
Karuna NeupaneAnandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal.
Jo SartoriInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Gemma SlinnBirmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Samuel I WatsonInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Richard LilfordInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
University of Birmingham · GBAnandaban Hospital · NPUniversity of Warwick · GB

Funding

Medical Research Council MR/V038591/1National Institute for Health Research NIHR: 200132
6 · The paper itself

Abstract

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 cm 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 registrationClinicalTrials.gov ISRCTN14933421 . Registered on 16 June 2020.

Indexed as

LeprosyPlatelet-Rich FibrinAdolescentAdultDrug Therapy, CombinationHumansLeprostatic AgentsLeukocytesNepalQuality of LifeRandomized Controlled Trials as TopicUlcerLeprostatic AgentsLeprosyL-PRFMycobacterium lepraeNepalUlcerWound

Identifiers

PMID34266456
PMCPMC8281567
OpenAlexW3162793234

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.