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Mfr of product identified in protocol to measure perfusion after treatment with sponsor device withdrew support from the study. Sponsor decided to cancel the investigation due to lack of adequate replacement.
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This is an observational, single-arm, on-label study. This clinical study will be conducted at up to 2 sites with a total of 10 subjects per site. All subjects will receive standard of care treatment which includes DFU treatments with the dermaPACE device.
The dermaPACE system will be used according to label along with standard of care. perfusion will be measured using TcPO2 methods and also using cleared hyperspectral imaging equipment. The intent of the study is to observe/measure oxygen saturation levels in the area of the treated wound before initiation of dermaPACE treatment, during the treatment period, and two weeks post treatment period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dermaPACE | Experimental | Non-sterile, single, Benchtop System that is comprised of a dermaPACE Control Console, PACE Applicator and foot pedal. The PACE applicator uses shockwave technology on acute and chronic defects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dermaPACE | Device | Shockwave application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin perfusion, effect on oxygenation level, by visit | Measurement of changes in oxygenation levels in superficial tissue before and after treatment with dermaPACE System. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing, effect on wound area, by visit | Measurement of changes in wound area at each visit | 10 weeks |
| Wound healing, effect on wound closure, by visit | Measurement of the rate of wound closure at each visit |
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Inclusion Criteria:
Exclusion Criteria:
A subject who:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Granick, MD FACS | University Hospital/Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Newark | New Jersey | 07103 | United States |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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Pulsed acoustic wave on-label application on acute and chronic defects of the skin and subcutaneous soft tissues
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| 10 weeks |
| 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 |