| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01656889 | Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers | PHASE3 | COMPLETED | 447 | — | — | Aug 1, 2012 | Dec 1, 2014 | Mar 14, 2016 | 50 | United States, Canada |
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.
| Arm | Type | Description |
|---|---|---|
| HP802-247 | EXPERIMENTAL | HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. |
| Vehicle | PLACEBO_COMPARATOR | Vehicle Control (fibrinogen solution \& thrombin solution without cells) |
| Name | Type | Description |
|---|---|---|
| HP-802-247 | BIOLOGICAL | HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days. |
| Vehicle | BIOLOGICAL | (fibrinogen solution \& thrombin solution without cells) |
Inclusion Criteria: * Provide informed consent. * Age ≥ 18 years and of either sex. * Willing to comply with protocol instructions, including allowing all study assessments. * Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 1...