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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Leg Ulcer	Device: Collagen ORC Antimicrobial Matrix (CAM)	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers
Study Start Date :	November 2004
Study Completion Date :	December 2005

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Effect of the 2 dressing regimens on rate of wound closure, ease of use, pain and adverse events, impact of the dressing regimen

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All

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.

Contacts and Locations

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Locations

United States, Florida
Wound Care Center
Ft Lauderdale, Florida, United States
Foot and Ankle Institute of South Florida
South Miami, Florida, United States
United States, Pennsylvania
Penn North Centers for Advanced Wound Care
Warren, Pennsylvania, United States

Sponsors and Collaborators

Ethicon, Inc.

Investigators

Study Director:	James Hart, MD	Ethicon, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00235209 History of Changes
Other Study ID Numbers:	400-04-002
First Posted:	October 10, 2005
Last Update Posted:	June 9, 2011
Last Verified:	October 2006

Additional relevant MeSH terms:

Ulcer; Leg Ulcer; Varicose Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases	Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Anti-Infective Agents; Anti-Bacterial Agents