SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spiracur, Inc.
ClinicalTrials.gov Identifier:
NCT00951080
First received: July 31, 2009
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.


Condition Intervention Phase
Ulcers
Wounds
Device: Traditional NPWT System
Device: SNaP Wound Care System
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.

Further study details as provided by Spiracur, Inc.:

Primary Outcome Measures:
  • Percent change in wound closure. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of wounds closed by four months. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Time to complete wound bed granulation. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • QOL outcomes. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: July 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SNaP Wound Care System Device: SNaP Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Active Comparator: Traditional NPWT System Device: Traditional NPWT System
Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.

Detailed Description:

This is a prospective, randomized, two-arm, non-inferiority, multi-center study comparing negative pressure therapy wound healing outcomes between the SNaP Wound Care System and traditional NPWT systems.

  Eligibility

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

Inclusion Criteria:

  • Subject has Venous Ulcer or Diabetic Ulcer with a surface area < 100 sq. cm and < 10 cm in widest diameter on lower extremity, but larger than 1 sq. cm
  • Subject has wound present for >30 days despite appropriate wound care
  • Subject has adequate blood perfusion (Defined as either transcutaneous oxygen measurements of the dorsum of the foot >30 mmHg or 0.7 < ABI <1.2)
  • Subject has wound in location amendable to creation of airtight seal around wound using NPWT dressings
  • Subject is able to understand and provide written consent
  • Subject able to understand and provide written consent
  • Male or non-pregnant female willing to have urine pregnancy test

Exclusion Criteria:

  • Subject has Active Infection (Redness, Swelling, Pain, Purulent Exudate)
  • Subject has Untreated Osteomyelitis
  • Subject has Allergy to Wound Care Products used in the study
  • Subject has Malignancy, Burn, Collagen Vascular Disease, Sickle Cell, Vasculopathy, or Pyoderma Gangrenosum Origin of Wound
  • Subject has Active Charcot Arthropathy of the Foot
  • Subject has study wound location on toes or plantar surface of foot
  • Subject has uncontrolled hyperglycemia (HbA1C >12%)
  • Subject has end stage renal disease requiring dialysis
  • Subject is undergoing active chemotherapy treatment that inhibits wound healing
  • Subject has had previous treatment with NPWT device, growth factors, hyperbaric oxygen, or bioengineered tissue product within 30 days of enrollment
  • Subject has a >30% wound surface area reduction in size at 1 week after screening visit
  • Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
  • Subject is unwilling or unable to comply with protocol requirements
  • Subject is pregnant
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951080

Locations
United States, Arizona
Hope Research Institute
Phoenix, Arizona, United States, 85050
Southern Arizona Limb Salvage Alliance (SALSA)
Tucson, Arizona, United States, 85724
United States, California
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
Jay Mukker, DPM Inc.
Fresno, California, United States, 93726
Palomar Pomerado Health Wound Care Center
Poway, California, United States, 92078
O'Connor Wound Care Clinic
San Jose, California, United States, 95128
John Muir Wound Care Center
Walnut Creek, California, United States, 94598
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Bethesda Health City Wound Care Center
Boynton Beach, Florida, United States, 33437
Wound Care on Wheels, LLC
Jacksonville, Florida, United States, 32216
Osceola Regional Medical Center
Kissimmee, Florida, United States, 34741
United States, Illinois
Weil Foot & Ankle Institute
Des Plaines, Illinois, United States, 60016
United States, Louisiana
LA Cardiovascular & Limb Salvage Center
Lafayette, Louisiana, United States, 70506
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
The Christ Hospital, Wound Healing Center
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
New Bridge Medical Research Corporation
Warren, Pennsylvania, United States, 16365
United States, Washington
Southwest Washington Medical Center Wound Healing Center
Vancouver, Washington, United States, 98664
Sponsors and Collaborators
Spiracur, Inc.
Investigators
Principal Investigator: David G Armstrong, DPM, Ph.D. Southern Arizona Limb Salvage Alliance (SALSA)
  More Information

Publications:
Responsible Party: Spiracur, Inc.
ClinicalTrials.gov Identifier: NCT00951080     History of Changes
Other Study ID Numbers: SNP041609
Study First Received: July 31, 2009
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Spiracur, Inc.:
ulcer
venous
diabetic
wounds and injuries

Additional relevant MeSH terms:
Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014