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

NCT ID: NCT00235196

Last Updated: 2006-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-12-31

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 diabetic foot ulcers.

Conditions

Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Collagen ORC Antimicrobial Matrix (CAM)

Intervention Type: DEVICE

Eligibility 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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

James Hart, MD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

Wound Care Center

Fort Lauderdale, Florida, United States

Foot and Ankle Institute of South Florida

South Miami, Florida, United States

Penn North Centers for Advanced Wound Care

Warren, Pennsylvania, United States

Countries

United States

Other Identifiers

400-04-001

Identifier Type: -

Identifier Source: org_study_id