AMNIODERM+ Medical Device Clinical Study

BioHealing s.r.o.

Status: Completed

Conditions: Diabetic Foot; Non-healing Wound

Treatments: Device: AMNIODERM+

Study type: Observational

Funder types: Industry

Identifiers

NCT06442865

AD+29082022ZP

Details and patient eligibility

About

This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC. Prospective data will contain information about wound treatment by AMNIODERM+®.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Retrospective data

Description:

Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion. Retrospective data will contain information about the subject's history and wound treatment by SoC.

Treatment:

Device: AMNIODERM+

Prospective data

Description:

Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion. Prospective data will contain information about wound treatment by AMNIODERM+®.

Treatment:

Device: AMNIODERM+