Trials / Completed
CompletedNCT05923749
A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers
A Prospective Randomised Controlled Study Demonstrating the Clinical Benefit of Biatain® Ag Relative to Cutimed® Siltec® Sorbact® for the Treatment of Venous Leg Ulcers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biatain Ag | Biatain with silver |
| DEVICE | Cutimed Siltec Sorbact | comparator device |
Timeline
- Start date
- 2023-06-29
- Primary completion
- 2025-01-29
- Completion
- 2025-01-29
- First posted
- 2023-06-28
- Last updated
- 2025-05-22
Locations
13 sites across 4 countries: United States, Denmark, Germany, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05923749. Inclusion in this directory is not an endorsement.