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| Name | Class |
|---|---|
| Serena Group | OTHER |
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Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
This study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OneStep Foot Scanner | This study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue Drop Foot Scanner | Other | Subjects with eligible wound will receive a BlueDrop® OneStep Foot Scanner™. They are instructed to step on the scale each morning. The Bluetooth technology transmits a photograph and thermal image to the central monitoring nurse at BlueDrop®. All information transmitted is compliant with HIPPA regulations. Subjects that are unable to use the scale will receive a phone call at months 3,6, 9 and 12 months to determine if the foot has remained closed. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Recurrence | To demonstrate durability of closure (rate of recurrence) of subjects with a closed diabetic foot ulcer during the CAMPX clinical trial comparing subjects treated with Single Layer Amniotic Membrane (SLAM) plus standard of care (SOC) to subjects treated with SOC alone. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Virtual Long-Term Follow Up | To evaluate the effectiveness of virtual clinical trial technology in the conduct of a long-term follow up trial. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be drawn from diabetic subjects who have previously completed the CAMPX trial and achieved complete closure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bennett Sarver | Contact | 1-833-865-6300 | info@serenagroups.com | |
| Thomas Serena, MD | Contact | 1-833-865-6300 | info@serenagroups.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit Foot and Ankle | Recruiting | Clinton Township | Michigan | 48038 | United States |
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|
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014456 | Ulcer |
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005534 | Foot Diseases |
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