Trials / Terminated
TerminatedNCT04178525
Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Primex ehf · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ChitoCare gel | ChitoCare gel is based on chitosan and used as an addition to standard care, accordingly with dressing change for 10 weeks. |
| DEVICE | Placebo gel | Placebo gel is used as an addition to standard care, accordingly with dressing change for 10 weeks. |
Timeline
- Start date
- 2018-08-02
- Primary completion
- 2020-09-22
- Completion
- 2020-09-22
- First posted
- 2019-11-26
- Last updated
- 2020-11-13
Locations
5 sites across 2 countries: Croatia, Slovenia
Source: ClinicalTrials.gov record NCT04178525. Inclusion in this directory is not an endorsement.