Evidence map›Paper›PMID 40240289›Full record

Trial reportInternational wound journal2025

A Randomised Controlled Clinical Study Comparing the Efficacy and Safety of an Autologous Standardised Leukocyte-Poor Platelet Gel With Standard Care for the Treatment of Chronic Neuropathic Diabetic Foot Ulcers.

Sylvaine Clavel, Chantal Denizot, Bruno Boëzennec, Antoine Turzi, Nizar Albache

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in International wound journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

2 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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

5 authors.

Sylvaine ClavelDepartment of Endocrinology, SOS Group-Hotel Dieu, Le Creusot, France.
Chantal DenizotPre-Re-Diab Network, Le Creusot, France.
Bruno BoëzennecRegenLab SA, Le Mont-sur-Lausanne, Switzerland.
Antoine TurziRegenLab SA, Le Mont-sur-Lausanne, Switzerland.
Nizar AlbacheDepartment of Endocrinology, SOS Group-Hotel Dieu, Le Creusot, France.

Funding

RegenLab SA (Le Mont-sur-Lausanne, Switzerland)
6 · The paper itself

Abstract

This randomised controlled clinical trial compared the efficacy of a standardised autologous platelet gel (RegenWound gel) (n = 48) with a standard care treatment (hydrocellular or hydrocolloid dressing) (n = 48) for the treatment of hard-to-heal foot ulcers in type 1 or 2 diabetes mellitus patients > 18 years old. The primary outcomes were the percentage of ulcers healed 6 weeks after treatment commenced. The secondary outcomes were the average healing time, the time course of the healing process, the local tolerance, and the acceptability of the treatment by the patient compared to the standard treatment. At the 6 weeks end-of-treatment visit (ETV), 56.5% of the patients in the RegenWound gel group and 20.0% of the patients in the control group had completely healed. Healing continued to evolve after the ETV and reached 77.3% at end-of-study visit 2 (12 weeks) in the RegenWound gel group, compared to 35.1% for the control group. The treatment was well tolerated and safe. RegenWound gel could be an effective treatment for diabetic foot ulcers, with most patients being healed within 6 weeks of treatment, and on average 1 to 2 treatments being needed. Trial Registration: ISRCTN10032417.

Indexed as

Blood PlateletsDiabetic FootWound HealingAdultAgedChronic DiseaseFemaleGelsHumansMaleMiddle AgedTreatment OutcomeGelsdiabetic foot ulcerplatelet‐rich plasmaPRP gelrandomised controlled clinical trialRegenWound gel

Identifiers

PMID40240289
PMCPMC12003047

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.