Leg Ulcer
Conditions
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.
Interventions
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness of CAM in VLU by comparing the reduction in wound area during a 12-week treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of the 2 dressing regimens on rate of wound closure, ease of use, pain and adverse events, impact of the dressing regimen | — |
Countries
United States
Outcome results
None listed