Evidence map›Paper›PMID 36556977›Full record

ArticleMedicina (Kaunas, Lithuania)2022

Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study): An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale.

Dured Dardari, Louis Potier, Ariane Sultan, Maude Francois, Jocelyne M'Bemba, Benjamin Bouillet, Lucy Chaillous, Laurence Kessler, Aurelie Carlier, Abdulkader Jalek and 8 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Medicina (Kaunas, Lithuania), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04537520 (Interventional Multi-Center Post Market Randomized Controlled Open-Label Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Hard to Heal Diabetic Foot Wounds), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 24% 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.

NCT04537520 nacompletednot on this map

Interventional Multi-Center Post Market Randomized Controlled Open-Label Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Hard to Heal Diabetic Foot Wounds

TypeinterventionalSponsorCentre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteRan2020 to 2022Enrolled180ConditionsDiabetes, Diabetic Foot UlcerArmsKerecis Omega3 Wound
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Gender Affirming Revision Vaginoplasty Utilizing Decellularized Fish Skin Xenograft: Surgical Technique and Outcomes.International braz j urol : official journal of the Brazilian Society of Urology
    Article
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

18 authors at 10 institutions in 2 countries.

Dured DardariDiabetic Foot Unit, Centre Hospitalier sud Francilien Corbeil Essonnes, 91100 Corbeil-Essonnes, France.
Louis PotierDiabetology Department, CHU Bichat-Claude Bernard, 75018 Paris, France.
Ariane SultanDiabetology Nutrition Department, CHU Montpelier, Université de Montpellier, 34090 Montpellier, France.
Maude FrancoisDiabetology Department, CHU Reims, 51100 Reims, France.
Jocelyne M'BembaDepartment of Diabetology, CHU Cochin, 75000 Paris, France.
Benjamin BouilletDepartment of Endocrinology-Diabetology, Dijon University Hospital, 21000 Dijon, France.
Lucy ChaillousDepartment of Endocrinology, Metabolic Diseases and Nutrition, University Hospital of Nante, 44000 Nantes, France.
Laurence KesslerDepartment of Diabetology, CHU Strasbourg, 67000 Strasbourg, France.ORCID 0000-0002-1769-5625
Aurelie CarlierDiabetology Department, CHU Bichat-Claude Bernard, 75018 Paris, France.
Abdulkader JalekDiabetology Nutrition Department, CHU Montpelier, Université de Montpellier, 34090 Montpellier, France.ORCID 0000-0002-7800-4859
Ayoub SbaaDepartment of Diabetology, CHU Strasbourg, 67000 Strasbourg, France.
Laurent OrlandoCERITD (Center for Study and Research for Improvement of the Treatment of Diabetes), Bioparc-Genopole Evry-Corbeil, 91042 Evry, France.
Elise BobonyCERITD (Center for Study and Research for Improvement of the Treatment of Diabetes), Bioparc-Genopole Evry-Corbeil, 91042 Evry, France.
Bruno DetournayCEMKA, 43 boulevard du Maréchal Joffre, 92340 Bourg-la-Reine, France.ORCID 0000-0001-7843-4608
Hilmar KjartanssonLandspitali University Hospital, 105 Reykjavik, Iceland.
Ragna Bjorg ArsaelsdottirLandspitali University Hospital, 105 Reykjavik, Iceland.
Baldur Tumi BaldurssonLandspitali University Hospital, 105 Reykjavik, Iceland.
Guillaume CharpentierCERITD (Center for Study and Research for Improvement of the Treatment of Diabetes), Bioparc-Genopole Evry-Corbeil, 91042 Evry, France.
Genopole (France) · FRReykjavík University · ISUniversité Claude Bernard Lyon 1 · FRCemka-Eval (France) · FRCentre Hospitalier Sud Francilien · FRCentre Hospitalier Universitaire de Reims · FRCentre National de la Recherche Scientifique · FRHôpital Cochin · FRInserm · FRUniversité de Montpellier · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCell and/or tissue-based wound care products have slowly advanced in the treatment of non-healing ulcers, however, few studies have evaluated the effectiveness of these devices in the management of severe diabetic foot ulcers.

methodThis study (KereFish) is part of a multi-national, multi-centre, randomised, controlled clinical investigation (Odin) with patients suffering from deep diabetic wounds, allowing peripheral artery disease as evaluated by an ankle brachial index equal or higher than 0.6. The study has parallel treatment groups: Group 1 treatment with Kerecis

conclusionThis study has received the ethics committee approval of each participating country. Inclusion of participants began in March 2020 and ended in July 2022. The first results will be presented in March 2023. The study is registered in ClinicalTrials.gov as Identifier: NCT04537520.

Indexed as

Diabetes MellitusDiabetic FootSkin TransplantationAnimalsDouble-Blind MethodHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicStandard of CareWound Healingcell and/or tissue-based wound care productsdiabetes foot ulcerintact fish skin graft

Identifiers

PMID36556977
PMCPMC9786154
OpenAlexW4311075460

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.