AMNIODERM+ Medical Device Clinical Study

NCT ID: NCT06442865

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2023-03-30

Brief Summary

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+®.

Conditions

Non-healing Wound; Diabetic Foot

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Retrospective data

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.

AMNIODERM+

Intervention Type: DEVICE

A common surgical approach in chronic wound treatment aims at the promotion of epithelization by a combination of debridement manipulations (removal of non-vital tissues) and infection/inflammation management using antibacterial wound dressings (antibiotics or silver covering). The advantages of biomaterials can be attributed to their unique mechanical, immunological, and regenerative properties.

The product will be evaluated in the subjects not responding to SoC.

Prospective data

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+®.

AMNIODERM+

Intervention Type: DEVICE

A common surgical approach in chronic wound treatment aims at the promotion of epithelization by a combination of debridement manipulations (removal of non-vital tissues) and infection/inflammation management using antibacterial wound dressings (antibiotics or silver covering). The advantages of biomaterials can be attributed to their unique mechanical, immunological, and regenerative properties.

The product will be evaluated in the subjects not responding to SoC.

Interventions

AMNIODERM+

A common surgical approach in chronic wound treatment aims at the promotion of epithelization by a combination of debridement manipulations (removal of non-vital tissues) and infection/inflammation management using antibacterial wound dressings (antibiotics or silver covering). The advantages of biomaterials can be attributed to their unique mechanical, immunological, and regenerative properties.

The product will be evaluated in the subjects not responding to SoC.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioHealing s.r.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Národní Endokrinologický a Diabetologický ústav

Ľubochňa, , Slovakia

Countries

Slovakia

Other Identifiers

AD+29082022ZP

Identifier Type: -

Identifier Source: org_study_id