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Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers

NCT03754465 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-01-23

No results posted yet for this study

Summary

This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.

Conditions

  • Diabetic Foot Ulcer

Interventions

BIOLOGICAL

ALLO-ASC-DFU

Application of ALLO-ASC-DFU Sheet to diabetic foot ulcer

PROCEDURE

Hydrogel SHEET(Vehicle control)

Application of Hydrogel SHEET to diabetic foot ulcer

Sponsors & Collaborators

  • Anterogen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • David G. Armstrong, MD.Ph D. · University of Southern California

  • Alexander M. Reyzelman, DPM · Center for Clinical Research

  • Young Nathan, DPM · Martinsville Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2023-10-23
Completion
2023-10-23
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 NCT03754465 on ClinicalTrials.gov