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

Smith & Nephew

Status: Completed

Conditions: Venous Leg Ulcers; Diabetic Foot Ulcers

Treatments: Device: PICO System; Device: tNPWT System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02470806

CE-052PIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

PICO System

Experimental group

Description:

Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface

Treatment:

Device: PICO System

tNPWT System

Active Comparator group

Description:

Traditional NPWT (tNPWT) from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.

Treatment:

Device: tNPWT System