Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
NCT ID: NCT01656889
Last Updated: 2016-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
447 participants
INTERVENTIONAL
2012-08-31
2014-12-31
Brief Summary
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This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HP802-247
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
HP-802-247
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
Vehicle
Vehicle Control (fibrinogen solution \& thrombin solution without cells)
Vehicle
(fibrinogen solution \& thrombin solution without cells)
Interventions
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HP-802-247
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
Vehicle
(fibrinogen solution \& thrombin solution without cells)
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years and of either sex.
* Willing to comply with protocol instructions, including allowing all study assessments.
* Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
* Arterial supply adequacy confirmed
* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
* Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
* Acceptable state of health and nutrition
Exclusion Criteria
* Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
* Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
* Refusal of or inability to tolerate compression therapy.
* Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
* History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
* Any prior exposure to HP802-247 or its vehicle.
18 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Healthpoint
INDUSTRY
Responsible Party
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Principal Investigators
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Herbert B Slade, MD
Role: STUDY_CHAIR
Chief Medical Officer
Tommy Lee, MSHS
Role: STUDY_DIRECTOR
Associate Director Clinical Operations
Robert Kirsner, MD
Role: PRINCIPAL_INVESTIGATOR
Investigator
William Marston, MD
Role: PRINCIPAL_INVESTIGATOR
Investigator
Locations
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Glendale, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Carlsbad, California, United States
Castro Valley, California, United States
Fresno, California, United States
Laguna Hills, California, United States
Long Beach, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
Stockton, California, United States
Sylmar, California, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
South Miami, Florida, United States
Tamarac, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Jacksonville, Illinois, United States
North Chicago, Illinois, United States
Springfield, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Cambridge, Massachusetts, United States
Las Vegas, Nevada, United States
Emerson, New Jersey, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Akron, Ohio, United States
Tulsa, Oklahoma, United States
Dunmore, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
St. George, Utah, United States
Roanoke, Virginia, United States
Tacoma, Washington, United States
Vancovuer, British Columbia, Canada
Greater Sudbury, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Sherbrooke, Quebec, Canada
Countries
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References
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Marston WA, Ennis WJ, Lantis JC 2nd, Kirsner RS, Galiano RD, Vanscheidt W, Eming SA, Malka M, Cargill DI, Dickerson JE Jr, Slade HB; HP802-247 Study Group. Baseline factors affecting closure of venous leg ulcers. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):829-835.e1. doi: 10.1016/j.jvsv.2017.06.017.
Other Identifiers
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802-247-09-029
Identifier Type: -
Identifier Source: org_study_id
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