AMNIODERM+ Medical Device Clinical Study

Diabetic Foot Clinical Trial

— AMNIODERM+  

Official title:

Freeze-dried Amniotic Membrane in the Treatment of Non-healing Wounds: a Single-arm, Retrospectivelyprospective Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06442865
• Other study ID #: AD+29082022ZP
• Status: Completed
• Start date: November 16, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: June 2024
• Source: BioHealing s.r.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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+®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Non-healing Wound

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Slovakia	Národní Endokrinologický a Diabetologický ústav	Lubochna

Sponsors (1)

Lead Sponsor	Collaborator
BioHealing s.r.o.

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-healing wounds measuring	Analyses of primary and secondary endpoints: The error rate During data collection, a change was made to the CIP regarding complete wound closure (wound heal). Whether a wound was healed was determined by the opinion of the investigator and not by the size of the wound as measured by Imito® application. The error rate of the Imito® measuring application in determining the size of the wound was 10 %, i.e. based on that and clinical experience the threshold of 0.1 cm2 was determined. Wounds smaller than or equal to 0.1 cm2 were considered as complete closure. The investigator confirmed the wound closure in an accompanying comment in the eCRF.	6 + 12 weeks