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

October 12, 2006 updated by: Ethicon, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Ft. Lauderdale, Florida, United States
        • Wound Care Center
      • South Miami, Florida, United States
        • Foot and Ankle Institute of South Florida
    • Pennsylvania
      • Warren, Pennsylvania, United States, 16365
        • Penn North Centers for Advanced Wound Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Quality of life
Rate of wound closure
Ease of use and adverse events
Wound odor
Wound characteristics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

October 13, 2006

Last Update Submitted That Met QC Criteria

October 12, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 400-04-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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