View Clinical Trial (Medical Research Study)
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
| City: |
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Daly City |
| State: |
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California |
| Zip Code: |
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94015 |
| Conditions: |
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Acute and Chronic Wounds - Pressure Ulcers - Trauma Wounds - Diabetic Foot Ulcers - Venous Stasis Ulcers |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Wound < 10 cm in greatest diameter
- Patient >18 years of age
- Willing and able to sign informed consent
Exclusion Criteria:
- Patients with wound-related cellulitis
- Patients with thick eschar at wound base post debridement
- Patients with wounds located in an area not amenable to forming an air- tight seal
- Ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid
arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or
pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's
syndrome
- Patient has untreated osteomyelitis
- Patient is allergic to wound care products
- Patient wounds with exposed blood vessels not suitable for negative pressure therapy
- Pregnant or pregnancy-suspected patients
- Subject actively participating in other clinical trials that conflict with the
current study
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| NCT ID: |
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NCT01113658 |
| Primary Contact: |
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Principal Investigator
Kristine K Nemes, DPM
Seton Hospital
Kristine Nemes, DPM
Phone: 650-755-3338
Email: drnemes@dcfeet.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Daly City, California 94015
United States
Kristine Nemes, DPM
Phone: 650-755-3338
Email: drnemes@dcfeet.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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