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

Completed · Not applicable

Conditions studied: Ulcers, Wounds

In brief

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.

Key facts

Study ID: NCT00951080
Run by: 3M
People needed: 132
Starts: 2009-07-01
Expected to finish: 2011-03-01
Last updated by the study team: 2022-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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