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Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.

NCT07209475 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2025-10-07

No results posted yet for this study

Summary

This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.

Conditions

  • Diabetic Foot Ulcer (DFU)
  • Amnio-Maxx

Interventions

BIOLOGICAL

Amnio-Maxx® Dual Layer Amnion Patch

Application of Amnio-Maxx® Dual Layer Amnion Patch

OTHER

Standard of Care (Investigator Choice)

Cleansing, debridement, wound documentation, off-loading

Sponsors & Collaborators

  • Royal Biologics

    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
2025-08-14
Primary Completion
2026-08-14
Completion
2026-08-14
FDA Drug
Yes

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 NCT07209475 on ClinicalTrials.gov