Skip to main content
OpenTrials
Completed

NCT Number: NCT00852995

Dose Finding Study of HP802-247 in Venous Leg Ulcers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Stasis Ulcers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aging Rehabilitation & Geriatric Care Research Center, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HP802-247

Biological

One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.

Placebo (vehicle)

Biological

Placebo (Vehicle) consisting of:

Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution

Primary outcomes

  1. The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.

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

    For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.

Secondary outcomes

  1. Kaplan-Meier Probability of Non-Closure

    Time frame: 14 weeks - the final visit for one subject was delayed by two weeks

    This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.

  2. Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.

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

    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.

  3. Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13

    Time frame: Over the 12 week treatment period or until the wound closed, which ever occurred first.

    The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.

  4. Percentage of Participants With Complete Wound Closure at Each Visit

    Time frame: Weekly, over the 12 week treatment period

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

  5. 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: Weekly, over the 12 week treatment period

    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. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.

  6. Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.

    Time frame: 14 weeks - the final visit for one subject was delayed by two weeks

    This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.

Sponsors and collaborators

Lead sponsor

Healthpoint

Industry

Registry information

Official study title

A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 27, 2009
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.