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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00951080
Recruitment Status : Completed
First Posted : August 4, 2009
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.

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 diabetic and venous ulcer wounds.

Condition or disease Intervention/treatment Phase
Ulcers Wounds Device: Traditional NPWT System Device: SNaP Wound Care System Not Applicable

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 systems.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.
Study Start Date : July 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SNaP Wound Care System Device: SNaP Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Active Comparator: Traditional NPWT System Device: Traditional NPWT System
Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.




Primary Outcome Measures :
  1. Percent Change in Wound Area [ Time Frame: Baseline and 16 weeks ]
    The percent change in wound area as measured from Visitrak tracings (Value at 16 weeks minus value at baseline / value at baseline)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951080


Locations
Show Show 17 study locations
Sponsors and Collaborators
KCI USA, Inc.
Investigators
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Principal Investigator: David G Armstrong, DPM, Ph.D. Southern Arizona Limb Salvage Alliance (SALSA)
Publications of Results:
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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT00951080    
Other Study ID Numbers: SNP041609
First Posted: August 4, 2009    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: October 2020
Keywords provided by KCI USA, Inc.:
ulcer
venous
diabetic
wounds and injuries
Additional relevant MeSH terms:
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Ulcer
Wounds and Injuries
Pathologic Processes