Evidence map›Paper›PMID 38909998›Full record

Trial reportBMJ open diabetes research & care2024

A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study).

Matevž Slivnik, Maja Navodnik Preložnik, Mojca Fir, Janja Jazbar, Nanča Čebron Lipovec, Igor Locatelli, Hélène Liette Lauzon, Vilma Urbančič Rovan

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open diabetes research & care, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04178525 (A Randomized, Parallel, Double Blind, Placebo Controlled, Multicentre, Two Arms Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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.

NCT04178525 naterminatednot on this map

A Randomized, Parallel, Double Blind, Placebo Controlled, Multicentre, Two Arms Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds

TypeinterventionalSponsorPrimex ehfRan2018 to 2020Enrolled46ConditionsDiabetic Foot UlcerArmsChitoCare gel, Placebo gel
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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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

8 authors.

Matevž SlivnikVizera d.o.o, Ljubljana, Slovenia matevz.slivnik@vizera.eu.ORCID 0000-0002-6339-6060
Maja Navodnik PreložnikGeneral Hospital Celje, Celje, Slovenia.
Mojca FirVizera d.o.o, Ljubljana, Slovenia.
Janja JazbarUniversity of Ljubljana Faculty of Pharmacy, Ljubljana, Slovenia.
Nanča Čebron LipovecUniversity of Ljubljana Faculty of Pharmacy, Ljubljana, Slovenia.
Igor LocatelliUniversity of Ljubljana Faculty of Pharmacy, Ljubljana, Slovenia.ORCID 0000-0002-0052-8986
Hélène Liette LauzonPrimex ehf, Siglufjörður, Iceland.
Vilma Urbančič RovanUniversity Medical Centre Ljubljana, Ljubljana, Slovenia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo assess the efficacy of a chitosan-based gel (ChitoCare) for the treatment of non-healing diabetic foot ulcers (DFUs). RESEARCH DESIGN AND

methodsForty-two patients with chronic DFUs were randomized to the ChitoCare or placebo gel for a 10-week treatment period and 4-week follow-up. The primary study end point was the rate of complete wound closure at week 10, presented as relative rate.

resultsThirty patients completed the 10-week treatment and 28 completed the 4-week follow-up. The ChitoCare arm achieved 16.7% complete wound closure at week 10 vs 4.2% in the placebo arm (p=0.297), 92.0% vs 37.0% median relative reduction in wound surface area from baseline at week 10 (p=0.008), and 4.62-fold higher likelihood of achieving 75% wound closure at week 10 (p=0.012). Based on the results of the Bates-Jensen Wound Assessment Tool, the wound state at week 10 and the relative improvement from the baseline were significantly better (median 20 vs 24 points, p=0.018, and median 29.8% vs 3.6%, p=0.010, respectively).

conclusionsChitoCare gel increased the rate of the DFU healing process. Several secondary end points significantly favored ChitoCare gel. TRIAL REGISTRATION NUMBER: NCT04178525.

Indexed as

ChitosanDiabetic FootGelsWound HealingAgedChronic DiseaseDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisTreatment OutcomeChitosanGelsclinical studydiabetes complicationsdiabetic footwound healing

Identifiers

PMID38909998
PMCPMC11328628

What OpenQuestion holds

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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.