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Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

NCT06572839 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-04-30

No results posted yet for this study

Summary

This randomized controlled study evaluates the adjuvant use of Amnio-Maxx in patients with diabetic foot ulcers

Conditions

  • Diabetic Foot Ulcer

Interventions

OTHER

Amnio-Maxx

Amnio-Maxx Dual Layer Amnion Patch is processed using aseptic techniques, treated with a saline solution and dehydrated.

Sponsors & Collaborators

  • Capsicure, LLC

    lead NETWORK

Principal Investigators

  • Windy Cole, DPM · Capsicure, LLC

  • Marissa Docter, RN, BSN, MD · Capsicure, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-25
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 NCT06572839 on ClinicalTrials.gov