Status:
COMPLETED
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
Lead Sponsor:
3M
Conditions:
Ulcers
Wounds
Eligibility:
All Genders
18+ years
Phase:
NA
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 diabeti...
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 syste...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00951080
Start Date
July 1 2009
End Date
March 1 2011
Last Update
August 1 2022
Active Locations (17)
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1
Hope Research Institute
Phoenix, Arizona, United States, 85050
2
Southern Arizona Limb Salvage Alliance (SALSA)
Tucson, Arizona, United States, 85724
3
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
4
Jay Mukker, DPM Inc.
Fresno, California, United States, 93726