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The purpose of this study is to assess the performance of the bio-ConneKtâ„¢ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open one-arm clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Population | Study population are subjects at least 18 years old and of any ethnic background with a full thickness diabetic foot ulcer or venous leg ulcer, where the ulcer has been diagnosed/present for greater than 4 weeks duration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to complete wound closure | Time to complete wound closure and percent wounds healed at 12 weeks | Weekly assessment up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Wound Closure | Mean and median wound size changes at 4, 6, 12 & 24 weeks, along with ulcer recurrence and/or device related adverse events. | 4, 6, 12 & 24 weeks |
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Inclusion Criteria:
A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale) or a venous leg ulcer confirmed with duplex ultrasound
The ulcer has been diagnosed/present for greater than 4 weeks duration.
Three or fewer ulcers separated by > 3.0 cm distance
Post-debridement, the ulcer size must be > 5 sq cm
Ankle / brachial index is between 0.7 to 1.2 and or one of the following must be present:
At least 18 years old
Able and willing to read and sign a voluntary written informed consent
Able and willing to attend scheduled follow-up visits and study related exams
Exclusion Criteria:
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A total of 20 patients with DFU (n=10) and VLU (n=10) will be considered in this study if they sign the informed consent, and meet all inclusion criteria and none of the exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elmer Croushore, MD | Contact | 352-538-3180 | ||
| Chandra Nataraj, PhD | Contact | 352-514-4269 | cnataraj@mlmbiologics.com |
| Name | Affiliation | Role |
|---|---|---|
| Elmer Croushore, MD | NFRMC Wound Therapy Services | Principal Investigator |
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| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D017719 | Diabetic Foot |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D014648 | Varicose Veins |