Trials / Completed
CompletedNCT01129986
A Post Marketing Clinical Study Utilizing DermaStream and Saline in Venous Ulcers
A Post Marketing Clinical Study Utilizing DermaStream and Saline for Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremity
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- EnzySurge · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
An open-label, prospective, controlled, two-step approach, post-marketing clinical study, applying DermaStream with saline streaming, in conjunction with a sustained multi-compression wrap, on healthy individuals and on patients with a venous stasis ulcer of the lower extremity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DermaStream | Five treatment days. On each day DermaStream application for up to 4 hours of saline streaming. |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2010-07-01
- Completion
- 2011-11-01
- First posted
- 2010-05-25
- Last updated
- 2013-09-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01129986. Inclusion in this directory is not an endorsement.