SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds - Full Text View

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:

Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial. Wound Repair Regen. 2011 Mar-Apr;19(2):173-80. doi: 10.1111/j.1524-475X.2010.00658.x.


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

ClinicalTrials.gov processed this record on February 27, 2015