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

Phase 4

Completed

• Conditions: Leg Ulcer

• Registration Number: NCT00235209
• Lead Sponsor: Ethicon, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-06
• Study First Posted: 2005-10-10
• Study Completion: 2005-12
• Status Verified: 2006-10
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical effectiveness of CAM in VLU by comparing the reduction in wound area during a 12-week treatment period.

Secondary Outcome Measures

Name	Time	Method
Effect of the 2 dressing regimens on rate of wound closure, ease of use, pain and adverse events, impact of the dressing regimen

Trial Locations

Locations (3)

Penn North Centers for Advanced Wound Care; 🇺🇸 Warren, Pennsylvania, United States

Wound Care Center; 🇺🇸 Ft Lauderdale, Florida, United States

Foot and Ankle Institute of South Florida; 🇺🇸 South Miami, Florida, United States