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Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers

NCT06681428 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-02-10

No results posted yet for this study

Summary

The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.

Conditions

  • Diabetic Foot Ulcer (DFU)
  • Chronic Foot Ulcers

Interventions

OTHER

Allograft

Placental-based Allografts

Sponsors & Collaborators

  • Professional Education and Research Institute

    collaborator OTHER

  • Tides Medical

    lead INDUSTRY

Principal Investigators

  • David G Armstrong, DPM, MD, PhD · Keck School of Medicine of USC

  • Frank Burrows, MBA, EMT, BCMAS, CWCA · Tides Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-14
Primary Completion
2026-11-18
Completion
2026-11-18

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 NCT06681428 on ClinicalTrials.gov