AMNIODERM+ Medical Device Clinical Study

Inclusion criteria

• Males and females over 18 years of age
• Type 1 or Type 2 diabetes mellitus
• 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)
• History of an evaluable defect ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion
• Size of a wound to be evaluated 2 to 16 cm2
• Wound treatment can be provided either on an inpatient or outpatient basis, based on the doctor's decision
• The subject agrees to periodic visits to the clinical trial site during their participation in the clinical trial
• The subject is able to understand the clinical trial information
• Signed informed consent form
• Data on previous wound care are available in the subject medical documentation

Exclusion criteria

• Necrotic wound requiring surgical treatment
• Pregnancy or breastfeeding
• Venous etiology of ulceration
• Burns or chemical burns
• Clinical manifestations of systemic infection
• Undermined wound edges
• The wound involves deeper structures (bone, tendons, joints)
• Inadequately controlled diabetes mellitus with HbA1c > 12 % (DCCT) diabetes mellitus
• Renal insufficiency with eGF < 30ml/min/1.73m2
• Infected ulceration either Stage ≥2 according to EWMA Position Document (2006) (Appendix II) or with CRP >10
• Topical treatment with any growth factor-based products