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The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
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The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and system performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNaP | Experimental | SNaP disposable, mechanically powered Negative Pressure Wound Therapy System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNaP Wound Care System | Device | The intervention is negative pressure wound therapy (NPWT) with the Spiracur SNaP Wound Care system for the treatment of a variety of acute and chronic wounds including pressure ulcers, trauma wounds, diabetic foot ulcers, venous stasis ulcers, and skin grafts. The Spiracur SNaP Wound Care system weighs less than 4 ounces, does not utilize an electric pump (device has no electrically powered parts), is fully disposable after use, and is designed for particularly small chronic wounds that require advanced wound care management. It delivers NPWT at a constant pressure level over several days without any required adjustments by the patient or clinician. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of complaints about device use and operation | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristine K Nemes, DPM | Seton Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Center for Advanced Wound Care | Daly City | California | 94015 | United States | ||
| The SF Center For Advanced Wound Care At |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D017719 | Diabetic Foot |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
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|
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| Daly City |
| California |
| 94015 |
| United States |
| D014652 |
| Vascular Diseases |
| 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 |