Clinical trial NCT01737762: Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
Official title: A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Leg Ulcers
Keywords: Venous leg ulcer
ulcer
Venous stasis
compression
venous
venous stasis ulcer
vlu
wound
varicose veins
venous insufficiency
dvt
deep vein thrombosis
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 155
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 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 and Drug Administration (FDA).

At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.

Detailed description: 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 16-week treatment period. Vehicle looks the same as HP802-247 but contains no cells. Target wound status is evaluated at each study visit (closed, open, reopened). At wound closure or completion of treatment all subject will enter an observational safety followed up period which ends at one year after initial exposure to test article.

Eligibility criteria: Inclusion Criteria:

* 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 \>12 cm2 to ≤ 36 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:

* 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.

Primary outcomes:
measure: Wound Closure
timeFrame: 16 Weeks
Secondary outcomes:
measure: Time in Days to Closure
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Carlsbad
country: United States
state: California
city: Castro Valley
country: United States
state: California
city: Fair Oaks
country: United States
state: California
city: Fresno
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Washington, D.C.
country: United States
state: District of Columbia
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Jacksonville
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Saginaw
country: United States
state: Michigan
city: Washington
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Bayonne
country: United States
state: New Jersey
city: Hoboken
country: United States
state: New Jersey
city: East Meadow
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Willoughby
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Dunmore
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Knoxville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
city: Calgary
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Sherbrooke
country: Canada
state: Quebec
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Healthpoint
name: Herbert B Slade, MD
role: STUDY_CHAIR
affiliation: Healthpoint
name: Tommy Lee, MSHS
role: STUDY_DIRECTOR
affiliation: University of Miami
name: Robert Kirsner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: William Marston, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.