Dose Finding Study of HP802-247 in Venous Leg Ulcers

Phase 2

Completed

• Conditions: Venous Leg Ulcer; Venous Stasis Ulcers
• Interventions: Biological: HP802-247; Biological: Placebo (Vehicle)

• Registration Number: NCT00852995
• Lead Sponsor: Healthpoint

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Primary Completion: 2011-04
• Study Completion: 2011-07
• Disposition First Submitted: 2013-09-12
• Disposition First Submitted QC: 2013-09-19
• Disposition First Posted: 2013-09-26
• Results First Submitted: 2016-02-15
• Results First Submitted QC: 2016-02-15
• Results First Posted: 2016-03-14
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A - Low Q7D	HP802-247	Low dose HP802-247, applied at each visit
C - High Q7D	HP802-247	High dose HP802-247, applied at each visit
B - Low Q14D	HP802-247	Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
E - Vehicle	Placebo (Vehicle)	Placebo (Vehicle), applied at each visit
D - High Q14D	HP802-247	High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12

Primary Outcome Measures

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

Name	Time	Method
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13	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.
Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.	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.
Kaplan-Meier Probability of Non-Closure	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.
Percentage of Participants With Complete Wound Closure at Each Visit	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.
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.	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.
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.	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.

Trial Locations

Locations (30)

Robert J. Snyder; 🇺🇸 Tamarac, Florida, United States

New England Sinai Hospital; 🇺🇸 Stoughton, Massachusetts, United States

Passavant Area Hospital; 🇺🇸 Jacksonville, Illinois, United States

Rosalind Franklin University; 🇺🇸 North Chicago, Illinois, United States

Center for Clinical Research; 🇺🇸 Castro Valley, California, United States

Dixie Regional Medical Center's Wound Clinic; 🇺🇸 St. George, Utah, United States

University of AZ College of Medicine; 🇺🇸 Tucson, Arizona, United States

ILD Consulting, Inc.; 🇺🇸 Encinitas, California, United States

Overlook Hospital Wound Healing Program; 🇺🇸 Summit, New Jersey, United States

Providence Sacred Heart Medical Center Wound Clinic; 🇺🇸 Spokane, Washington, United States

Vincent Giacalone; 🇺🇸 Emerson, New Jersey, United States

Aging Rehabilitation & Geriatric Care Research Center; 🇨🇦 London, Ontario, Canada

Center for Advanced Wound Care; 🇺🇸 Reading, Pennsylvania, United States

Southwest Regional Wound Care Center; 🇺🇸 Lubbock, Texas, United States

St. Luke's Roosevelt Hospital Center; 🇺🇸 New York, New Jersey, United States

Doctors Research Network; 🇺🇸 South Miami, Florida, United States

Harrisburg Foot and Ankle Center; 🇺🇸 Harrisburg, Pennsylvania, United States

Southern Illinois University; 🇺🇸 Springfield, Illinois, United States

Vascular Surgery Associates; 🇺🇸 Los Angeles, California, United States

UCSD Wound Treatment and Research Center; 🇺🇸 San Diego, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins Wound Center; 🇺🇸 Baltimore, Maryland, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Advanced Foot and Ankle Center; 🇺🇸 Las Vegas, Nevada, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Arlington Research Center; 🇺🇸 Arlington, Texas, United States

Wound Care Consultants; 🇺🇸 Dallas, Texas, United States

Peripheral Vascular Associates; 🇺🇸 San Antonio, Texas, United States

Lake Washington Vascular, LLC; 🇺🇸 Bellevue, Washington, United States