SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
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ClinicalTrials.gov Identifier: NCT00951080 |
Recruitment Status
:
Completed
First Posted
: August 4, 2009
Last Update Posted
: April 9, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcers Wounds | Device: Traditional NPWT System Device: SNaP Wound Care System | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 132 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial. |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: SNaP Wound Care System |
Device: SNaP Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
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Active Comparator: Traditional NPWT System |
Device: Traditional NPWT System
Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
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- Percent change in wound closure. [ Time Frame: 16 weeks ]
- Percent of wounds closed by four months. [ Time Frame: 16 weeks ]
- Time to complete wound bed granulation. [ Time Frame: 16 weeks ]
- QOL outcomes. [ Time Frame: 16 weeks ]

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

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 ClinicalTrials.gov identifier (NCT number): NCT00951080
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 |
Principal Investigator: | David G Armstrong, DPM, Ph.D. | Southern Arizona Limb Salvage Alliance (SALSA) |
Publications of Results:
Responsible Party: | Spiracur, Inc. |
ClinicalTrials.gov Identifier: | NCT00951080 History of Changes |
Other Study ID Numbers: |
SNP041609 |
First Posted: | August 4, 2009 Key Record Dates |
Last Update Posted: | April 9, 2013 |
Last Verified: | April 2013 |
Keywords provided by Spiracur, Inc.:
ulcer venous diabetic wounds and injuries |
Additional relevant MeSH terms:
Wounds and Injuries Ulcer Pathologic Processes |