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This is a randomized controlled multi center study on diabetic patients with the aim of evaluating the efficacy of the adipose tissue processed with the SyntrFugeâ„¢ system in diabetic patients with diabetic foot ulcers. In particular, it will be evaluated whether the microsized fat graft will be able to shorten the healing times of these wounds. Patients will be randomized to the treatment group with adipose tissue processed with the SyntrFugeâ„¢ system (injection of autologous microsized adipose tissue) or to the control group represented by the standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SyntrFuge System | Experimental | Adipose tissue microsized via the SyntrFuge System |
|
| Standard of Care | Other | Offloading |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyntrFuge System | Device | Microsized Adipose Tissue |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects with study wound deemed closed at 12 weeks | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roanoke | Roanoke | Virginia | 24153 | United States |
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| Standard of Care |
| Procedure |
Offloading |
|
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| 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 |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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