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. |
Resource links provided by NLM:
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 (Adult, Senior) |
| 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
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:
|
Wounds and Injuries Ulcer Pathologic Processes |
ClinicalTrials.gov processed this record on September 23, 2016