SkinTE® in the Treatment of Venous Leg Wounds

Exclusion Criteria

• •Subjects with a BMI ≥45
• •Index ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency.
• •Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
• •Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
• •Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit (SV1).
• •History of radiation at the ulcer site (regardless of time since last radiation treatment).
• •Index ulcer has been previously treated or will need to be treated with any prohibited therapies, such as chlorhexidine or collagenase. (See Section 7.3 of this protocol for a list of prohibited medications and therapies).
• •Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \> 10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the study.
• •Study ulcer requiring negative pressure wound therapy during the course of the trial.
• •Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
• •Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
• •Subject is pregnant or breast-feeding.
• •Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization.
• •Subjects with end stage renal disease as evidenced by a creatinine greater than 3.0mg/dl within 120 days of randomization.
• •Target wound has presence of local active soft tissue infection involving the treatment site.
• •Index ulcer has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/randomization visit.
• •In the opinion of the Investigator, evidence of unstable human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening.
• •Vascular surgery; arterial or venous to the affected extremity within 30 days of screening