A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers

Conditions
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Leg Ulcer

Intervention / Treatment
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* Device: Collagen ORC Antimicrobial Matrix (CAM)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Collagen ORC Antimicrobial Matrix (CAM)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effectiveness of CAM in VLU by comparing the reduction in wound area during a 12-week treatment period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  |