Clinical trial NCT00235209: A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers
Official title: A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Leg Ulcer
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on venous leg ulcers.


Eligibility criteria: Inclusion Criteria:

* Be 18 years of age or older.
* Have evidence of venous insufficiency documented by venous duplex scanning or impedance plethysmography within the past 6 months. The study report must contain the actual terms "venous incompetence" or it must be repeated.
* Have a venous ulcer of \>3 but \<25 cm2 in area, by planimetry.
* Have a venous ulcer that has been open continuously for \>1 but \<18 months prior to treatment.
* Have been in the prescribed compression for at least 7 days immediately prior to randomization, but no more than 14 days (consecutive or non-consecutive).
* If female, the subject must: be postmenopausal without menses for at least 1 year, or have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy, or have a negative serum Human Chorionic Gonadotropin (HCG) and be willing to practice an approved form of birth control for the duration of the trial.
* Subject agrees to participate in the study, including all study related procedures and evaluations and documents this agreement by signing the IRB-approved informed consent.

Exclusion Criteria:

* Have the designated study wound below the malleolus or above the popliteal fossa.
* Have been treated with becaplermin (PDGF-BB) or any other topical recombinant therapy to the study wound within the 30 days prior to randomization.
* Have had the study wound treated, at any time, with a skin substitute or an autologous growth factor.
* Have had a surgical procedure to treat venous or arterial disease of the affected limb within the past 90 days.
* Have evidence of significant arterial insufficiency (i.e. an ankle brachial index of \< 0.8). Subjects with an ABI \>1.0 must have a toe brachial index (TBI) of \> 0.6 or a supine transcutaneous oxygen measurement on the affected leg and distal to the wound of \>30mmHg.
* Have clinical evidence of active infection at the wound site.
* Have evidence of active vasculitis, cellulitis or collagen vascular disease.
* Have participated in a clinical trial of an investigational agent within the last 30 days.
* Have significant acute or chronic diseases (i.e., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or infectious diseases) that are not adequately controlled by medical treatment as determined by the Investigator's judgment.
* Have diabetes mellitus with a hemoglobin A1c \> 10%.
* Have an active skin disease, such as psoriasis, which could impair the ability to assess the study wound.
* Have an allergy to the components of the dressings used in this study.
* Require concomitant use of pentoxifylline or clopidogrel bisulfate during the study.
* Have undergone enzymatic debridement of the study wound at any time during the 7 days prior to the first application of study treatment.
* Have any requirement for the use of systemic steroids or immunosuppressive or cytotoxic compounds during the period of the study or received low-dose steroid therapy for more than 5 days within the past year.
* Expect to undergo hyperbaric oxygen therapy at any time during the study.

Primary outcomes:
measure: Clinical effectiveness of CAM in VLU by comparing the reduction in wound area during a 12-week treatment period.
Secondary outcomes:
measure: Effect of the 2 dressing regimens on rate of wound closure, ease of use, pain and adverse events, impact of the dressing regimen
Other outcomes:
Locations:
city: Ft Lauderdale
country: United States
facility: Wound Care Center
state: Florida
city: South Miami
country: United States
facility: Foot and Ankle Institute of South Florida
state: Florida
city: Warren
country: United States
facility: Penn North Centers for Advanced Wound Care
state: Pennsylvania
Study officials:
affiliation: Ethicon, Inc.
name: James Hart, MD
role: STUDY_DIRECTOR
References: