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AMNIODERM+ Medical Device Clinical Study

NCT06442865 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-06-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • BioHealing s.r.o.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2023-03-30
Completion
2023-03-30

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06442865 on ClinicalTrials.gov