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Clinical Evaluation of the SNaP Wound Care System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01113658
Recruitment Status : Unknown
Verified October 2010 by KCI USA, Inc..
Recruitment status was:  Recruiting
First Posted : April 30, 2010
Last Update Posted : October 25, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Acute and Chronic Wounds Pressure Ulcers Trauma Wounds Diabetic Foot Ulcers Venous Stasis Ulcers Device: SNaP Wound Care System Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
Study Start Date : March 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Frequency of complaints about device use and operation [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Percent of wounds closed by 16 weeks [ Time Frame: 16 weeks ]
  2. Time to complete wound bed granulation [ Time Frame: 16 weeks ]
  3. Compliance with therapy [ Time Frame: 16 weeks ]
  4. Quality of life [ Time Frame: 16 weeks ]
  5. Percent of healing [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01113658

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Contact: Kristine Nemes, DPM 650-755-3338

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United States, California
San Francisco Center for Advanced Wound Care Recruiting
Daly City, California, United States, 94015
Contact: Kristine Nemes, DPM    650-755-3338   
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         
Sponsors and Collaborators
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Principal Investigator: Kristine K Nemes, DPM Seton Hospital
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Responsible Party: Martin Kwende, PhD/ Director, Clinical Affairs, Spiracur Inc. Identifier: NCT01113658    
Other Study ID Numbers: SNaP-113009
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010
Keywords provided by KCI USA, Inc.:
negative pressure wound therapy
SNaP Wound Care System
Additional relevant MeSH terms:
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Diabetic Foot
Varicose Ulcer
Foot Ulcer
Pressure Ulcer
Wounds and Injuries
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Varicose Veins