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

Study Overview
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Brief Summary
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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.

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

Conditions
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Foot Ulcer

Intervention / Treatment
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* Device: Collagen ORC Antimicrobial Matrix (CAM)


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Collagen ORC Antimicrobial Matrix (CAM)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of wound closure |  |  | 
| Ease of use and adverse events |  |  | 
| Wound odor |  |  | 
| Quality of life |  |  | 
| Wound characteristics |  |  |