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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spiracur, Inc.
ClinicalTrials.gov Identifier:
NCT00951080
First received: July 31, 2009
Last updated: April 5, 2013
Last verified: April 2013

July 31, 2009
April 5, 2013
July 2009
March 2011   (final data collection date for primary outcome measure)
Percent change in wound closure. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00951080 on ClinicalTrials.gov Archive Site
  • Percent of wounds closed by four months. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Time to complete wound bed granulation. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • QOL outcomes. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ulcers
  • Wounds
  • Device: Traditional NPWT System
    Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
  • Device: SNaP Wound Care System
    Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
  • Experimental: SNaP Wound Care System
    Intervention: Device: SNaP Wound Care System
  • Active Comparator: Traditional NPWT System
    Intervention: Device: Traditional NPWT System
Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial. Wound Repair Regen. 2011 Mar-Apr;19(2):173-80. doi: 10.1111/j.1524-475X.2010.00658.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00951080
SNP041609
No
Spiracur, Inc.
Spiracur, Inc.
Not Provided
Principal Investigator: David G Armstrong, DPM, Ph.D. Southern Arizona Limb Salvage Alliance (SALSA)
Spiracur, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP