Collagen ORC Antimicrobial Matrix (CAM) in Leg Ulcer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Leg Ulcer

Intervention / Treatment

Device: Collagen ORC Antimicrobial Matrix (CAM)

Study Type

Interventional

Enrollment

48

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria