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

Sponsored by 3M

About this trial

Last updated 3 years ago

Study ID

SNP041609

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 14 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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