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

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)