Clinical trial NCT00852995: Dose Finding Study of HP802-247 in Venous Leg Ulcers
Official title: A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Leg Ulcer
Venous Stasis Ulcers
Keywords: Venous Leg Ulcer (VLU)
Venous Stasis Ulcer (VSU)
VLU
VSU
Leg Ulcer
Leg Wound
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2009-02-27
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.
timeFrame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Secondary outcomes:
measure: Kaplan-Meier Probability of Non-Closure
timeFrame: 14 weeks - the final visit for one subject was delayed by two weeks
measure: Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
timeFrame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
measure: Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
timeFrame: Over the 12 week treatment period or until the wound closed, which ever occurred first.
measure: Percentage of Participants With Complete Wound Closure at Each Visit
timeFrame: Weekly, over the 12 week treatment period
measure: 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.
timeFrame: Weekly, over the 12 week treatment period
measure: Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.
timeFrame: 14 weeks - the final visit for one subject was delayed by two weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of AZ College of Medicine
state: Arizona
city: Castro Valley
country: United States
facility: Center for Clinical Research
state: California
city: Encinitas
country: United States
facility: ILD Consulting, Inc.
state: California
city: Los Angeles
country: United States
facility: Vascular Surgery Associates
state: California
city: San Diego
country: United States
facility: UCSD Wound Treatment and Research Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: South Miami
country: United States
facility: Doctors Research Network
state: Florida
city: Tamarac
country: United States
facility: Robert J. Snyder
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Jacksonville
country: United States
facility: Passavant Area Hospital
state: Illinois
city: North Chicago
country: United States
facility: Rosalind Franklin University
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Wound Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Stoughton
country: United States
facility: New England Sinai Hospital
state: Massachusetts
city: Las Vegas
country: United States
facility: Advanced Foot and Ankle Center
state: Nevada
city: Emerson
country: United States
facility: Vincent Giacalone
state: New Jersey
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital Wound Healing Program
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Harrisburg
country: United States
facility: Harrisburg Foot and Ankle Center
state: Pennsylvania
city: Reading
country: United States
facility: Center for Advanced Wound Care
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Dallas
country: United States
facility: Wound Care Consultants
state: Texas
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
city: San Antonio
country: United States
facility: Peripheral Vascular Associates
state: Texas
city: St. George
country: United States
facility: Dixie Regional Medical Center's Wound Clinic
state: Utah
city: Bellevue
country: United States
facility: Lake Washington Vascular, LLC
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center Wound Clinic
state: Washington
city: London
country: Canada
facility: Aging Rehabilitation & Geriatric Care Research Center
state: Ontario
Study officials:
affiliation: Healthpoint
name: Herbert B Slade, MD
role: STUDY_CHAIR
affiliation: University of North Carolina
name: William Marston, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Robert Kirsner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert J Snyder
name: Robert J Snyder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirsner RS, Marston WA, Snyder RJ, Lee TD, Cargill DI, Slade HB. Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2012 Sep 15;380(9846):977-85. doi: 10.1016/S0140-6736(12)60644-8. Epub 2012 Aug 3.