View Clinical Trial (Medical Research Study)

SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds - NCT00951080-32216(Clinical Trial 385372)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Jacksonville
State:  
FL
Zip Code: 32216
Conditions: Ulcers - Wounds
Purpose: 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.
Study summary: 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.
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
Study is available at: Wound Care on Wheels, LLC
Jacksonville, FL 32216
United States
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.