Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers

Browse trials for

• Varicose Ulcer 377
• Leg Ulcer 298
• Ulcer 2,023

Keywords

• Venous leg ulcer
• ulcer
• venous stasis
• compression
• venous
• venous stasis ulcer
• vlu
• wound
• varicose veins
• venous insufficiency
• dvt
• deep vein thrombosis

Study arms

• Experimental
  HP802-247 plus compression therapy

  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 10(6th) cells per mL every 14 days. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.

  Biological: HP802-247

• Placebo comparator
  HP802-247 Vehicle plus compression therapy

  fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly.

  Other: HP802-247 Vehicle

Interventions

• BiologicalHP802-247

  Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.

• OtherHP802-247 Vehicle

  HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

  Also known as: Placebo

Primary outcomes

1. Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline

   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 prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.

   Time frame: Weekly, over 12 Weeks or until wound closure, which ever occurred first

Secondary outcomes

1. Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.

   This key secondary outcome was based on a Cox Proportional Hazard Analysis.

   Time frame: 12 Weeks

2. Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (Days) to Closure Over the 12-Week Treatment Period From Baseline.

   This key secondary outcome was based on a Kaplan-Meier Survival analysis.

   Time frame: 12 weeks

3. Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline

   For subjects who dropped from the study, their remaining visit values were imputed using LOCF. Treatment groups were compared for percentage of participants with closed wounds at each treatment visit.

   Time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first

4. Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure

   Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.

   Time frame: Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure.

5. Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks

   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.

   Time frame: Baseline and Weekly, over the 12 week treatment period

6. Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks

   Target leg pain were 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.

   Time frame: Baseline and Weekly, over the 12 week treatment period

Baseline characteristics

Publications

• Marston WA, Ennis WJ, Lantis JC 2nd, Kirsner RS, Galiano RD, Vanscheidt W, Eming SA, Malka M, Cargill DI, Dickerson JE Jr, Slade HB; HP802-247 Study Group. Baseline factors affecting closure of venous leg ulcers. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):829-835.e1. doi: 10.1016/j.jvsv.2017.06.017. PubMed 29037354 ↗