Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
3M
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
