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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.

Conditions
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Ulcers, Wounds

Intervention / Treatment
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* Device: Traditional NPWT System
* Device: SNaP Wound Care System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNaP Wound Care System<br> | Device: SNaP Wound Care System<br>* Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.<br>|
| Active Comparator: Traditional NPWT System<br> | Device: Traditional NPWT System<br>* Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Wound Area | The percent change in wound area as measured from Visitrak tracings (Value at 16 weeks minus value at baseline / value at baseline) | Baseline and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcer, venous, diabetic, wounds and injuries