Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
228 participants
INTERVENTIONAL
2009-02-28
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
NCT01737762
A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
NCT02154087
Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
NCT01658618
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
NCT01656889
Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247
NCT01970657
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A - Low Q7D
Low dose HP802-247, applied at each visit
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.
B - Low Q14D
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
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.
C - High Q7D
High dose HP802-247, applied at each visit
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.
D - High Q14D
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
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.
E - Vehicle
Placebo (Vehicle), applied at each visit
Placebo (Vehicle)
Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Healthpoint
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Herbert B Slade, MD
Role: STUDY_CHAIR
Healthpoint
William Marston, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Robert Kirsner, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Robert J Snyder, MD
Role: PRINCIPAL_INVESTIGATOR
Robert J Snyder
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of AZ College of Medicine
Tucson, Arizona, United States
Center for Clinical Research
Castro Valley, California, United States
ILD Consulting, Inc.
Encinitas, California, 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
Doctors Research Network
South Miami, Florida, United States
Robert J. Snyder
Tamarac, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Passavant Area Hospital
Jacksonville, Illinois, United States
Rosalind Franklin University
North Chicago, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Johns Hopkins Wound Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
New England Sinai Hospital
Stoughton, Massachusetts, United States
Advanced Foot and Ankle Center
Las Vegas, Nevada, United States
Vincent Giacalone
Emerson, New Jersey, United States
St. Luke's Roosevelt Hospital Center
New York, New Jersey, United States
Overlook Hospital Wound Healing Program
Summit, New Jersey, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Harrisburg Foot and Ankle Center
Harrisburg, Pennsylvania, United States
Center for Advanced Wound Care
Reading, Pennsylvania, United States
Arlington Research Center
Arlington, Texas, United States
Wound Care Consultants
Dallas, Texas, United States
Southwest Regional Wound Care Center
Lubbock, Texas, United States
Peripheral Vascular Associates
San Antonio, Texas, United States
Dixie Regional Medical Center's Wound Clinic
St. George, Utah, United States
Lake Washington Vascular, LLC
Bellevue, Washington, United States
Providence Sacred Heart Medical Center Wound Clinic
Spokane, Washington, United States
Aging Rehabilitation & Geriatric Care Research Center
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
802-247-09-015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.