Dose Finding Study of HP802-247 in Venous Leg Ulcers
A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers
1 other identifier
interventional
228
2 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2009
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 26, 2009
CompletedFirst Posted
Study publicly available on registry
February 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
March 14, 2016
CompletedOctober 24, 2016
September 1, 2016
2.2 years
February 26, 2009
February 15, 2016
September 13, 2016
Conditions
Keywords
Outcome Measures
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.
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
Secondary Outcomes (6)
Kaplan-Meier Probability of Non-Closure
14 weeks - the final visit for one subject was delayed by two weeks
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
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.
Percentage of Participants With Complete Wound Closure at Each Visit
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.
Weekly, over the 12 week treatment period
- +1 more secondary outcomes
Study Arms (5)
A - Low Q7D
EXPERIMENTALLow dose HP802-247, applied at each visit
B - Low Q14D
EXPERIMENTALLow dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
C - High Q7D
EXPERIMENTALHigh dose HP802-247, applied at each visit
D - High Q14D
EXPERIMENTALHigh 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 COMPARATORPlacebo (Vehicle), applied at each visit
Interventions
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) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healthpointlead
Study Sites (30)
University of AZ College of Medicine
Tucson, Arizona, 85724, United States
Center for Clinical Research
Castro Valley, California, 94546, United States
ILD Consulting, Inc.
Encinitas, California, 92024, United States
Vascular Surgery Associates
Los Angeles, California, 90048, United States
UCSD Wound Treatment and Research Center
San Diego, California, 92013, United States
University of Miami
Miami, Florida, 33186, United States
Doctors Research Network
South Miami, Florida, 33143, United States
Robert J. Snyder
Tamarac, Florida, 33321, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60154, United States
Passavant Area Hospital
Jacksonville, Illinois, 62650, United States
Rosalind Franklin University
North Chicago, Illinois, 60064, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Johns Hopkins Wound Center
Baltimore, Maryland, 21231, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
New England Sinai Hospital
Stoughton, Massachusetts, 02972, United States
Advanced Foot and Ankle Center
Las Vegas, Nevada, 89119, United States
Vincent Giacalone
Emerson, New Jersey, 07630, United States
St. Luke's Roosevelt Hospital Center
New York, New Jersey, 10025, United States
Overlook Hospital Wound Healing Program
Summit, New Jersey, 07901, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Harrisburg Foot and Ankle Center
Harrisburg, Pennsylvania, 17112, United States
Center for Advanced Wound Care
Reading, Pennsylvania, 19601, United States
Arlington Research Center
Arlington, Texas, 76011, United States
Wound Care Consultants
Dallas, Texas, 75093, United States
Southwest Regional Wound Care Center
Lubbock, Texas, 79410, United States
Peripheral Vascular Associates
San Antonio, Texas, 78205, United States
Dixie Regional Medical Center's Wound Clinic
St. George, Utah, 84770, United States
Lake Washington Vascular, LLC
Bellevue, Washington, 98004, United States
Providence Sacred Heart Medical Center Wound Clinic
Spokane, Washington, 99204, United States
Aging Rehabilitation & Geriatric Care Research Center
London, Ontario, N6C5J1, Canada
Related Publications (1)
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.
PMID: 22863328DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jamie E Dickerson, PhD
- Organization
- Smith & Nephew
Study Officials
- STUDY CHAIR
Herbert B Slade, MD
Healthpoint
- PRINCIPAL INVESTIGATOR
William Marston, MD
University of North Carolina
- PRINCIPAL INVESTIGATOR
Robert Kirsner, MD
University of Miami
- PRINCIPAL INVESTIGATOR
Robert J Snyder, MD
Robert J Snyder
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2009
First Posted
February 27, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2011
Study Completion
July 1, 2011
Last Updated
October 24, 2016
Results First Posted
March 14, 2016
Record last verified: 2016-09