Clinical trial NCT00951080: SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
Official title: Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcers
Wounds
Keywords: ulcer
venous
diabetic
wounds and injuries
Lead sponsor: 3M
Sponsor class: INDUSTRY
First posted: 2009-08-04
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Percent Change in Wound Area
timeFrame: Baseline and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona Limb Salvage Alliance (SALSA)
state: Arizona
city: Castro Valley
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Fresno
country: United States
facility: Jay Mukker, DPM Inc.
state: California
city: Poway
country: United States
facility: Palomar Pomerado Health Wound Care Center
state: California
city: San Jose
country: United States
facility: O'Connor Wound Care Clinic
state: California
city: Walnut Creek
country: United States
facility: John Muir Wound Care Center
state: California
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Boynton Beach
country: United States
facility: Bethesda Health City Wound Care Center
state: Florida
city: Jacksonville
country: United States
facility: Wound Care on Wheels, LLC
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Medical Center
state: Florida
city: Des Plaines
country: United States
facility: Weil Foot & Ankle Institute
state: Illinois
city: Lafayette
country: United States
facility: LA Cardiovascular & Limb Salvage Center
state: Louisiana
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital, Wound Healing Center
state: Ohio
city: Warren
country: United States
facility: New Bridge Medical Research Corporation
state: Pennsylvania
city: Vancouver
country: United States
facility: Southwest Washington Medical Center Wound Healing Center
state: Washington
Study officials:
affiliation: Southern Arizona Limb Salvage Alliance (SALSA)
name: David G Armstrong, DPM, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.