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

NCT00235196 | Completed Phase 4

• 1 other identifier: 400-04-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• Rate of wound closure

• Ease of use and adverse events

• Wound odor

• Quality of life

• Wound characteristics

Interventions

Collagen ORC Antimicrobial Matrix (CAM) DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (3)

Wound Care Center

Fort Lauderdale, Florida, United States

Location

Foot and Ankle Institute of South Florida

South Miami, Florida, United States

Location

Penn North Centers for Advanced Wound Care

Warren, Pennsylvania, 16365, United States

Location

MeSH Terms

Conditions

Foot Ulcer

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• James Hart, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: July 1, 2004
• Study Completion: December 1, 2005
• Last Updated: October 13, 2006

Record last verified: 2006-10

Locations

US (3)