About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 14 years ago
What is this trial about?
What are the participation requirements?
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