Trials / Terminated
TerminatedNCT00998673
Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers
Randomized Standard-of-Care-Controlled Trial of a Silica Gel Fiber (SGF) Wound Dressing in the Treatment of Chronic Venous Leg Ulcers
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds. It is applied as patch and will be hold in place by a secondary dressing for maintaining the moist wound environment. The study is aimed to demonstrate superiority over a standard wound treatment for chronic venous leg ulcers. The primary efficacy variable is time to healing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Silica Gel Fiber | Silica Gel Fiber (SGF) applications as required |
| DEVICE | Standard-of-Care | Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2011-06-01
- Completion
- 2011-06-01
- First posted
- 2009-10-20
- Last updated
- 2015-07-14
Locations
14 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00998673. Inclusion in this directory is not an endorsement.