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Clinical Evaluation of the SNaP Wound Care System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Spiracur, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Spiracur, Inc.
ClinicalTrials.gov Identifier:
NCT01113658
First received: April 28, 2010
Last updated: October 22, 2010
Last verified: October 2010
History of Changes
  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.


Condition Intervention Phase
Acute and Chronic Wounds
Pressure Ulcers
Trauma Wounds
Diabetic Foot Ulcers
Venous Stasis Ulcers
 Device: SNaP Wound Care System
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spiracur, Inc.:

Primary Outcome Measures:
  • Frequency of complaints about device use and operation [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent of wounds closed by 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Time to complete wound bed granulation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Compliance with therapy [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Percent of healing [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SNaP Wound Care System

    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.

    Other Names:
    • Spiracur SNaP Wound Care System
    • SNaP
    • The SNaP System
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113658

Contacts
Contact: Kristine Nemes, DPM 650-755-3338 drnemes@dcfeet.com

Locations
United States, California
The SF Center For Advanced Wound Care At Recruiting
Daly City, California, United States, 94015
Principal Investigator: Kristine Nemes, DPM            
Sub-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            
San Francisco Center for Advanced Wound Care Recruiting
Daly City, California, United States, 94015
Contact: Kristine Nemes, DPM     650-755-3338     drnemes@dcfeet.com    
Sponsors and Collaborators
Spiracur, Inc.
Investigators
Principal Investigator: Kristine K Nemes, DPM Seton Hospital
  More Information

No publications provided

Responsible Party: Martin Kwende, PhD/ Director, Clinical Affairs, Spiracur Inc.
ClinicalTrials.gov Identifier: NCT01113658     History of Changes
Other Study ID Numbers: SNaP-113009
Study First Received: April 28, 2010
Last Updated: October 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Spiracur, Inc.:
negative pressure wound therapy
NPWT
Spiracur
SNaP Wound Care System

Additional relevant MeSH terms:
Pressure Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Ulcer
Varicose Ulcer
Foot Ulcer
Diabetic Foot
Skin Ulcer
Skin Diseases
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
 Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Pathologic Processes
Varicose Veins
Leg Ulcer
Foot Diseases
Diabetic Angiopathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on June 17, 2013