SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
This study has been completed.
Sponsor:
Spiracur, Inc.
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
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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
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 June 18, 2013