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

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.

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%