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Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

NCT06550596 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Conditions

  • Diabetic Foot
  • Ulcer Foot
  • Foot Ulcer
  • Diabetic Foot Ulcer

Interventions

OTHER

Standard of Care

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Axolotl DualGraft + SOC

Participants will receive weekly applications of Axolotl DualGraft and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Sponsors & Collaborators

  • SerenaGroup, Inc.

    collaborator NETWORK

  • Axolotl Biologix

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2025-10-31
Completion
2025-10-31

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 NCT06550596 on ClinicalTrials.gov