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

Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235196
• Other study ID #: 400-04-001
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2005
• Last updated: October 12, 2006
• Start date: July 2004
• Est. completion date: December 2005

Study information

• Verified date: October 2006
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

Device:
• Collagen ORC Antimicrobial Matrix (CAM)

Locations

Country	Name	City	State
United States	Wound Care Center	Ft. 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

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups.
Secondary	Rate of wound closure
Secondary	Ease of use and adverse events
Secondary	Wound odor
Secondary	Quality of life
Secondary	Wound characteristics