Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)

Completed · Not applicable

Conditions studied: Venous Leg Ulcers, Diabetic Foot Ulcers

In brief

The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.

Key facts

Study ID

NCT02470806

Run by

Smith & Nephew, Inc.

People needed

164

Starts

2015-07-02

Expected to finish

2017-11-14

Last updated by the study team

2020-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide informed consent
• Age ≥ 18 years and of either sex
• Willing to comply with protocol instructions, including allowing all study assessments
• Have a Venous Leg Ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 36.0 cm2
• Target ulcer duration ≥ 4 weeks but ≤ 104 weeks (24 months)
• Have a Diabetic Foot Ulcer (DFU) present on any part of the plantar or dorsum surface of the foot, with a surface area ≥ 0.5 cm2 and ≤ 10.0 cm2
• Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
• Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months)
• Acceptable state of health and nutrition

You may not qualify if…

• Therapy with another investigational agent within thirty (30) days of Screening, or during the study Ulcers which are deemed as highly exuding, per the Investigator's discretion.
• Current diagnosis of osteomyelitis at the target wound location that is not currently receiving treatment [Documented history of resolved osteomyelitis is allowed].
• Subjects with a VLU: Refusal of or inability to tolerate compression therapy.
• Clinical evidence of target ulcer infection
• Current systemic therapy with cytotoxic drugs.
• Current therapy with chronic (> 10 days) oral corticosteroids.
• Previous treatment with NPWT device or hyperbaric oxygen within 7 days of screening.
• Malignancy in the target ulcer, or history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)

Where it is running

• ILD Consulting, Inc. — Carlsbad, California, United States
• Valley Foot & Ankle Specialty Providers — Fresno, California, United States
• The Sun Healthcare & Surgery Group — Martinez, California, United States
• Center for Clincial Research — San Francisco, California, United States
• Olive View - UCLA Medical Center — Sylmar, California, United States
• University of Miami — Miami, Florida, United States
• NW University Feinberg School of Medicine — Chicago, Illinois, United States
• Rosalind Franklin University of Med & Science — North Chicago, Illinois, United States
• Ochsner Health System — New Orleans, Louisiana, United States
• Rubin Institute for Advanced Orthopedics — Baltimore, Maryland, United States
• Advanced Foot & Ankle — Las Vegas, Nevada, United States
• Center for Advanced Wound Care — Wyomissing, Pennsylvania, United States
• Acclaim Bone & Joint — Fort Worth, Texas, United States
• Futuro Clinical Trials, LLC — McAllen, Texas, United States
• Carilion Clinic — Roanoke, Virginia, United States
• The Mayer Institute — Hamilton, Ontario, Canada
• Centre podiatrique et soins des plaies — Boucherville, Quebec, Canada

Full record on ClinicalTrials.gov

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