AMNIODERM+ Medical Device Clinical Study

Inclusion Criteria

• •1. Males and females over 18 years of age
• •2. Type 1 or Type 2 diabetes mellitus
• •3. Presence of a diabetic neuropathic or neuroischemic wound, anywhere on the leg, that has not healed at least 20% after the 6 weeks of the standard of care (SoC)
• •4. History of an evaluable defect ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion
• •5. Size of a wound to be evaluated 2 to 16 cm2
• •6. Wound treatment can be provided either on an inpatient or outpatient basis, based on the doctor's decision
• •7. The subject agrees to periodic visits to the clinical trial site during their participation in the clinical trial
• •8. The subject is able to understand the clinical trial information
• •9. Signed informed consent form
• •10. Data on previous wound care are available in the subject medical documentation