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Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.

NCT07219004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-21

No results posted yet for this study

Summary

This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.

Conditions

  • Lower Extremity Chronic Ulcers in Diabetics
  • Diabetic Foot Ulcer (DFU)

Interventions

OTHER

amniotic membrane

The intervention is a trial-layer human amnion/chorion/amnion composite graft

Sponsors & Collaborators

  • Serena Group

    collaborator OTHER

  • Tides Medical

    lead INDUSTRY

Principal Investigators

  • Thomas Serena, MD · Serena Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2023-09-27
Completion
2023-09-27

Countries

  • United States

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 NCT07219004 on ClinicalTrials.gov