Status:
COMPLETED
Evaluation of the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers
Lead Sponsor:
Ethicon, Inc.
Conditions:
Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00235196
Start Date
July 1 2004
End Date
December 1 2005
Last Update
October 13 2006
Active Locations (3)
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1
Wound Care Center
Fort Lauderdale, Florida, United States
2
Foot and Ankle Institute of South Florida
South Miami, Florida, United States
3
Penn North Centers for Advanced Wound Care
Warren, Pennsylvania, United States, 16365