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

This study has been completed.
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00235209
First received: October 6, 2005
Last updated: June 8, 2011
Last verified: October 2006
  Purpose

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 Intervention Phase
Leg Ulcer
Device: Collagen ORC Antimicrobial Matrix (CAM)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

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

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

Estimated Enrollment: 48
Study Start Date: November 2004
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235209

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

No publications provided

ClinicalTrials.gov Identifier: NCT00235209     History of Changes
Other Study ID Numbers: 400-04-002
Study First Received: October 6, 2005
Last Updated: June 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Cardiovascular Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014