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

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.

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Key information

Conditions

Ulcers Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer Wounds Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hope Research Institute, Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional NPWT System

Device

Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.

SNaP Wound Care System

Device

Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Aug 4, 2009
Registry last updated: Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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