Clinical Evaluation of the SNaP Wound Care System
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Cardiology, Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Dermatology / Plastic Surgery, Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2010 |
| End Date: | March 2013 |
| Contact: | Kristine Nemes, DPM |
| Email: | drnemes@dcfeet.com |
| Phone: | 650-755-3338 |
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
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.
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.
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
We found this trial at
2
sites
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