Phase 2
N=228
Dose Finding Study of HP802-247 in Venous Leg Ulcers
Venous Leg Ulcer · Venous Stasis Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT00852995 ↗Enrolled (actual)
228
Serious AEs
7.0%
Results posted
Mar 2016
Primary outcome: Primary: The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. — -77.11; -70.15; -68.14; -72.89 percent change — p=0.00028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HP802-247 (Biological); Placebo (Vehicle) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Healthpoint
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. |
-77.11; -70.15; -68.14; -72.89; -60.38 | 0.00028 sig |
| SECONDARY Kaplan-Meier Probability of Non-Closure |
1; 1; 0.977; 1; 1; 1 | — |
| SECONDARY Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. |
-22.94; -38.88; -27.89; -25.88; -34.97; -39.94 | .037 sig |
| SECONDARY Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 |
8; 17; 5; 6; 13; 22 | 0.0133 sig |
| SECONDARY Percentage of Participants With Complete Wound Closure at Each Visit |
0; 4.3; 2.3; 0; 2.2; 2.0 | 0.017 sig |
| SECONDARY Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. |
30.82; 21.11; 28.6; 29.84; 25.47; 21.68 | — |
| SECONDARY Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline. |
71; 50; 64; 57; 57 | 0.0211 sig |
Summary
This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.
Eligibility Criteria
Inclusion Criteria
- Provide informed consent.
- Willing to comply with protocol instructions, including allowing all study assessments.
- Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus.
- Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
- Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.
Exclusion Criteria
- Women who are pregnant or lactating
- Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
- A target ulcer of non-venous etiologies.
- Refusal of or inability to tolerate compression therapy.
- Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit.
- Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.
Data sourced from ClinicalTrials.gov (NCT00852995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.