Dose Finding Study of HP802-247 in Venous Leg Ulcers

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852995
• Other study ID #: 802-247-09-015
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2009
• Last updated: February 15, 2016
• Start date: February 2009
• Est. completion date: July 2011

Study information

• Verified date: February 2016
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Venous Stasis Ulcers

Intervention

Biological:
• HP802-247
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)
Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution

Locations

Country	Name	City	State
Canada	Aging Rehabilitation & Geriatric Care Research Center	London	Ontario
United States	Arlington Research Center	Arlington	Texas
United States	Johns Hopkins Wound Center	Baltimore	Maryland
United States	Lake Washington Vascular, LLC	Bellevue	Washington
United States	Boston Medical Center	Boston	Massachusetts
United States	Center for Clinical Research	Castro Valley	California
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Wound Care Consultants	Dallas	Texas
United States	Vincent Giacalone	Emerson	New Jersey
United States	ILD Consulting, Inc.	Encinitas	California
United States	Harrisburg Foot and Ankle Center	Harrisburg	Pennsylvania
United States	Passavant Area Hospital	Jacksonville	Illinois
United States	Advanced Foot and Ankle Center	Las Vegas	Nevada
United States	Vascular Surgery Associates	Los Angeles	California
United States	Southwest Regional Wound Care Center	Lubbock	Texas
United States	University of Miami	Miami	Florida
United States	St. Luke's Roosevelt Hospital Center	New York	New Jersey
United States	Rosalind Franklin University	North Chicago	Illinois
United States	Center for Advanced Wound Care	Reading	Pennsylvania
United States	Peripheral Vascular Associates	San Antonio	Texas
United States	UCSD Wound Treatment and Research Center	San Diego	California
United States	Doctors Research Network	South Miami	Florida
United States	Providence Sacred Heart Medical Center Wound Clinic	Spokane	Washington
United States	Southern Illinois University	Springfield	Illinois
United States	Dixie Regional Medical Center's Wound Clinic	St. George	Utah
United States	New England Sinai Hospital	Stoughton	Massachusetts
United States	Overlook Hospital Wound Healing Program	Summit	New Jersey
United States	Robert J. Snyder	Tamarac	Florida
United States	University of AZ College of Medicine	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.	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.	Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first	No
Secondary	Kaplan-Meier Probability of Non-Closure	This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.	14 weeks - the final visit for one subject was delayed by two weeks	No
Secondary	Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.	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.	Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first	No
Secondary	Proportion of Subjects Achieving = 50% Decrease in Target Wound Area From Baseline Through Week 13	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.	Over the 12 week treatment period or until the wound closed, which ever occurred first.	No
Secondary	Proportion of Subjects With Complete Wound Closure at Each Visit	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.	Weekly, over the 12 week treatment period	No
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.	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.	Weekly, over the 12 week treatment period	No
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.	This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.	14 weeks - the final visit for one subject was delayed by two weeks	No