Clinical trial NCT02470806: Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
Official title: A Prospective, Randomized, Comparative Effectiveness Study of a Single-Use, Negative Pressure Wound Therapy System (PICO) Versus a Traditional Negative Pressure Wound Therapy System (tNPWT) in the Treatment of Lower Extremity Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcers
Diabetic Foot Ulcers
Keywords: Venous leg ulcer
ulcer
venous stasis
compression
diabetic foot ulcers
dfu
vlu
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: The two types of NPWT systems include the tNPWT system that has successfully completed a coding verification request with CMS and has the following capabilities (e.g., range of negative pressure, connective tubing, canister, foam or gauze filler, and approved for home use), and a portable, canister-less, battery operated, disposable PICO system to see if there are any observed differences with regard to the clinical efficacy of the two devices.

Eligibility criteria: INCLUSION CRITERIA:

* 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

EXCLUSION CRITERIA

* 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)

Primary outcomes:
measure: Change in Ulcer Area From Baseline to the End of the Treatment Period
timeFrame: Baseline through 12 weeks
measure: Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period
timeFrame: Baseline through 12 weeks
Secondary outcomes:
measure: Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
timeFrame: Baseline through 12 weeks
measure: Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
timeFrame: Baseline through 12 weeks
measure: Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
timeFrame: Baseline through 12 weeks
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: ILD Consulting, Inc.
state: California
city: Fresno
country: United States
facility: Valley Foot & Ankle Specialty Providers
state: California
city: Martinez
country: United States
facility: The Sun Healthcare & Surgery Group
state: California
city: San Francisco
country: United States
facility: Center for Clincial Research
state: California
city: Sylmar
country: United States
facility: Olive View - UCLA Medical Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: NW University Feinberg School of Medicine
state: Illinois
city: North Chicago
country: United States
facility: Rosalind Franklin University of Med & Science
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Baltimore
country: United States
facility: Rubin Institute for Advanced Orthopedics
state: Maryland
city: Las Vegas
country: United States
facility: Advanced Foot & Ankle
state: Nevada
city: Wyomissing
country: United States
facility: Center for Advanced Wound Care
state: Pennsylvania
city: Fort Worth
country: United States
facility: Acclaim Bone & Joint
state: Texas
city: McAllen
country: United States
facility: Futuro Clinical Trials, LLC
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Hamilton
country: Canada
facility: The Mayer Institute
state: Ontario
city: Boucherville
country: Canada
facility: Centre podiatrique et soins des plaies
state: Quebec
Study officials:
affiliation: Smith & Nephew, Inc.
name: Andy Weymann, MD, MBA
role: STUDY_CHAIR
References: