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

Wounds Clinical Trial

Official title:

Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951080
• Other study ID #: SNP041609
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: March 2011

Study information

• Verified date: July 2022
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ulcer
• Ulcers
• Wounds
• Wounds and Injuries

Intervention

Device:
• Traditional NPWT System
Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
• SNaP Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Locations

Country	Name	City	State
United States	Bethesda Health City Wound Care Center	Boynton Beach	Florida
United States	Center for Clinical Research, Inc.	Castro Valley	California
United States	University of North Carolina	Chapel Hill	North Carolina
United States	The Christ Hospital, Wound Healing Center	Cincinnati	Ohio
United States	Weil Foot & Ankle Institute	Des Plaines	Illinois
United States	Jay Mukker, DPM Inc.	Fresno	California
United States	Wound Care on Wheels, LLC	Jacksonville	Florida
United States	Osceola Regional Medical Center	Kissimmee	Florida
United States	LA Cardiovascular & Limb Salvage Center	Lafayette	Louisiana
United States	Hope Research Institute	Phoenix	Arizona
United States	Palomar Pomerado Health Wound Care Center	Poway	California
United States	O'Connor Wound Care Clinic	San Jose	California
United States	Southern Arizona Limb Salvage Alliance (SALSA)	Tucson	Arizona
United States	Southwest Washington Medical Center Wound Healing Center	Vancouver	Washington
United States	John Muir Wound Care Center	Walnut Creek	California
United States	New Bridge Medical Research Corporation	Warren	Pennsylvania
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 multicen — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Wound Area	The percent change in wound area as measured from Visitrak tracings (Value at 16 weeks minus value at baseline / value at baseline)	Baseline and 16 weeks