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

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

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.

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.

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)