Evaluation of the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers

This study has been completed.
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00235196
First received: October 6, 2005
Last updated: October 12, 2006
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 diabetic foot ulcers.


Condition Intervention Phase
Foot 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: Treatment
Official Title: A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.

Secondary Outcome Measures:
  • Rate of wound closure
  • Ease of use and adverse events
  • Wound odor
  • Quality of life
  • Wound characteristics

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted).
  • Diagnosed Type 2 diabetic (i.e. not juvenile onset).
  • Have a DFU on the plantar surface of either foot.
  • Have a DFU of >4 wks but <6 months duration.
  • Willing and capable of cooperating to the extent and degree required by the study protocol

Exclusion Criteria:

  • Be < 1cm2 or >10cm2 in area, by planimetry.
  • Demonstrate overt signs of infection.
  • Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1).
  • Have visible exposed bone or tendon.
  • Have an adjacent thermal injury or wound of an etiology other than diabetes.
  • Be within 5 cm of any other wound, regardless of etiology.
  • Have received enzymatic debriding agents in the past 7 days.
  • Have received topical antibiotic therapy in the past 7 days.
  • Be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement.
  • Have exposed bone or tendon, after debridement

The study subject MUST NOT:

  • Have received previous treatment for the study ulcer by this Investigator.
  • Have more than 3 full thickness ulcers, in total.
  • Be pregnant or nursing an infant
  • Have a concurrent illness or condition which may interfere with wound healing, such as carcinoma, vasculitis, immune system disorders or connective tissue disorder.
  • Be a known alcohol or drug abuser.
  • Have received systemic corticosteroids, immunosuppressive or chemotherapeutic agents in the past 30 days.
  • Have received radiotherapy, which includes the lower extremity, at any time.
  • Have a marked Charcot foot or claw foot deformity which would limit the ability of the subject to wear or be compliant with the wearing of the standardized off-loading device used in this study.
  • Have received an investigational drug or device in the past 30 days.
  • Have a known hypersensitivity to bovine collagen, oxidized regenerated cellulose (ORC) or silver.
  • Be unwilling or unable to be fitted or compliant with the wearing of an ulcer off-loading device.
  • Known to be non-compliant or unlikely to complete the study.
  • Have ABPI < 0.7, OR, if ABPI >1.0 and toe pressure >0.6.
  • Have serum Creatinine > 3 mg/dL25. have Hgb A1C>9%
  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: NCT00235196

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, 16365
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: James Hart, MD Ethicon, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00235196     History of Changes
Other Study ID Numbers: 400-04-001
Study First Received: October 6, 2005
Last Updated: October 12, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014