MedTrace Logo

Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.

NCT04569409 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-09-22

No results posted yet for this study

Summary

This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 Foot Ulcer, compared to placebo therapy.

Conditions

  • Diabetic Foot Ulcer

Interventions

BIOLOGICAL

ALLO-ASC-DFU

Application of ALLO-ASC-DFU sheet to Diabetic Wagner grade 2 Foot Ulcer

PROCEDURE

Vehicle Sheet

Application of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer

Sponsors & Collaborators

  • Anterogen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • SeungKyu Han, MD. Ph D · Korea University Guro Hospital

  • BaekKyu Kim, MD. Ph D · Seoul National University Bundang Hospital

  • JunPio Hong, MD. Ph D · Asan Medical Center

  • JiUng Bak, MD. Ph D · Borame Medical Center

  • YeongCheol Seo, MD. Ph D · Bucheon St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2024-12-05
Completion
2024-12-05

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT04569409 on ClinicalTrials.gov