AMNIODERM+ Medical Device Clinical Study

Launched by BIOHEALING S.R.O. · May 29, 2024

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

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