Clinical trial
Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for…
NCT00485329 · EnzySurge, Industry · Completed
Key facts
| NCT number | NCT00485329 |
|---|---|
| Title | Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers |
| Official title | A Phase I/II Randomized, Double Blind, Placebo-Controlled Dose- Escalating Study, to Assess The Safety and Efficacy of Enzystream™ Debriding Solution (Papain) Applied by Dermastream™ Device for the Treatment of Lower Extremity Chronic Venous Ulcers |
| Acronym | ENZ-DER-002-IL |
| Lead sponsor | EnzySurge, Industry |
| Status | Completed |
| Phase | Phase 1/Phase 2 |
| Study type | Interventional |
| Conditions | Lower Extremity Chronic Venous Ulcers |
| Intervention type | Other |
| Interventions | Papain |
| Enrollment | 48 |
| Start date | Jul 1, 2007 |
| Primary completion | Mar 1, 2009 |
| Completion | Mar 1, 2009 |
| First posted | Jun 12, 2007 |
| Last update posted | May 25, 2010 |
| Countries | Israel |
At a glance
- 1–9 Study sites
- No Results posted
- 1–9 Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: