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

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)