A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers

Ethicon, Inc.3 sites in 1 country48 target enrollmentJuly 2004

ConditionsFoot Ulcer

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Foot Ulcer
Sponsor: Ethicon, Inc.
Enrollment: 48
Locations: 3
Primary Endpoint: Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2004

End Date

December 2005

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ethicon, Inc.

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