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Home » Clinical Trials » Diabetic Foot Ulcers

Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of SNaP Wound Care System

Research Study Title

Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System

Purpose

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.

To Learn more
Phase

4

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Spiracur, Inc.

Duration

29 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

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

Site Locations (2)

Country State City Zip Facility and Contact
United States California Daly City 94015 San Francisco Center for Advanced Wound Care
Kristine Nemes, DPM
650-755-3338
drnemes@dcfeet.com
United States California Daly City 94015 The SF Center For Advanced Wound Care At

Kristine Nemes, DPM
Principal Investigator

John R Crew, MD
Sub-Investigator

James W Stavosky, DPM
Sub-Investigator

Hermenegildo G Angeles, MD
Sub-Investigator

Divyang Patel, DPM
Sub-Investigator

Philip B Sanfilippo, DPM
Sub-Investigator

H Valle, MD
Sub-Investigator

Contact

Kristine Nemes, DPM
650-755-3338
E-mail:

NCT ID: NCT01113658

Date Last Changed: October 22, 2010

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