Trials / Completed
CompletedNCT01858272
Preliminary Testing of New Treatment for Chronic Leg Wounds
Phase I Trial to Evaluate the Safety of H5.020CMV.PDGF-b and Limb Compression Bandage for the Treatment of Venous Leg Ulcer (Trial A)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the efficacy, dosing, and safety of an intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer. The primary endpoint of this Phase I trial is the determination of the Maximum Tolerated Dose (MTD) for the intra-ulcer injection of H5.020CMV.PDGF-b.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | H5.020CMV.PDGF-b and limb compression bandage |
Timeline
- Start date
- 2004-09-01
- Primary completion
- 2008-08-01
- Completion
- 2009-06-01
- First posted
- 2013-05-21
- Last updated
- 2017-01-11
Source: ClinicalTrials.gov record NCT01858272. Inclusion in this directory is not an endorsement.