Status:
TERMINATED
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
Lead Sponsor:
Healthpoint
Conditions:
Venous Ulcer
Venous Stasis Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food ...
Detailed Description
See Brief Summary
Eligibility Criteria
Inclusion
- Provide informed consent.
- 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
- History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
- 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.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT01853384
Start Date
November 1 2013
End Date
February 1 2015
Last Update
October 3 2016
Active Locations (46)
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1
Anderlecht, Belgium
2
Brussels, Belgium
3
Edegen, Belgium
4
Ghent, Belgium