OBJECTIVE

Healing factors:

The study will evaluate the efficacy of dehydrated human placental tissue and standard of care versus the standard of care alone in the closure of non-healing diabetic foot ulcers and venous leg ulcers.

To demonstrate improvement in quality of life for subjects receiving a skin substitute plus SOC compared to SOC alone.

INCLUSION CRITERIA

• Subjects must be at least 18 years of age or older.
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
• The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
• The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• The target ulcer must be full thickness without exposed bone.