A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study).
BMJ Open Diabetes Res Care
; 12(3)2024 Jun 23.
Article
em En
| MEDLINE
| ID: mdl-38909998
ABSTRACT
INTRODUCTION:
To assess the efficacy of a chitosan-based gel (ChitoCare) for the treatment of non-healing diabetic foot ulcers (DFUs). RESEARCH DESIGN ANDMETHODS:
Forty-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.RESULTS:
Thirty 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).CONCLUSIONS:
ChitoCare gel increased the rate of the DFU healing process. Several secondary end points significantly favored ChitoCare gel. TRIAL REGISTRATION NUMBER NCT04178525.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Cicatrização
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Pé Diabético
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Quitosana
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Géis
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article