Trials / Completed
CompletedNCT03808181
An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds
An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds, Covered With Devitalised Tissue, During Six Weeks Treatment
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- RLS Global · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.
Detailed description
Approximately 58 subjects from at least two sites in Sweden will be included. Subjects presented with lower leg ulcer, covered with devitalised tissue for 50% or more and being candidate for cleansing, debridement/desloughing will be enrolled. Weekly application of Investigational Product for 6 weeks. Follow-up for wound status evaluation after 12 weeks from baseline. Total time in investigation is 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ChloraSolv | Weekly application of ChloraSolv for 6 weeks |
Timeline
- Start date
- 2019-01-31
- Primary completion
- 2020-04-30
- Completion
- 2020-06-30
- First posted
- 2019-01-17
- Last updated
- 2021-04-08
Locations
9 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT03808181. Inclusion in this directory is not an endorsement.