A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study)
Authors' conclusion
ChitoCare gel increased the rate of the DFU healing process. Several secondary end points significantly favored ChitoCare gel.
Study context
- Population
- Patients with chronic non-healing diabetic foot ulcers (DFUs)30 completed 10-week treatment
- Participants
- 42 patients
- Comparison
- ChitoCare chitosan-based gel vs placebo gel
- Primary endpoint
- Rate of complete wound closure, presented as relative rate
- Follow-up
- Week 10
Methodological detailsplacebo-controlled, 10-week treatment period and 4-week follow-up; 28 completed follow-up
- Placebo-controlled
- 10-week treatment period and 4-week follow-up; 28 completed follow-up
Primary result
As reported in the abstract
Complete wound closure
P = 0.297
Secondary outcomes
Bates-Jensen Wound Assessment Tool score (wound state) · week 10 · significantly better with ChitoCare
P = 0.018
Median
| Outcome | ChitoCare | Placebo | Fold higher likelihood | P value |
|---|---|---|---|---|
| Relative reduction in wound surface area from baseline · week 10 | 92.0% | 37.0% | P = 0.008 | |
| Achieving 75% wound closure · week 10 | 4.62 | P = 0.012 | ||
| Bates-Jensen score relative improvement from baseline · week 10Significantly better with ChitoCare | 29.8% | 3.6% | P = 0.010 |
Original publication
A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study). BMJ Open Diabetes Res Care. Published 23 June 2024. doi:10.
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