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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen ORC Antimicrobial Matrix (CAM) | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical effectiveness of CAM in DFU by comparing the reduction in wound area between 2 treatment groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of wound closure | ||
| Ease of use and adverse events | ||
| Wound odor |
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Inclusion Criteria:
Exclusion Criteria:
The study subject MUST NOT:
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| Name | Affiliation | Role |
|---|---|---|
| James Hart, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wound Care Center | Fort Lauderdale | Florida | United States | |||
| Foot and Ankle Institute of South Florida |
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| Quality of life |
| Wound characteristics |
| South Miami |
| Florida |
| United States |
| Penn North Centers for Advanced Wound Care | Warren | Pennsylvania | 16365 | United States |
| ID | Term |
|---|---|
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
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