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

NCT03370874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-08-25

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 Foot Ulcer, compared to placebo therapy.

Conditions

  • Diabetic Foot Ulcer

Interventions

BIOLOGICAL

ALLO-ASC-DFU

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

PROCEDURE

Vehicle sheet

Application of Vehicle sheet to diabetic foot ulcer

Sponsors & Collaborators

  • Anterogen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Seung-Kyu Han, MD. Ph D. · Korea University Guro Hospital

  • Ki-Won Young, MD. Ph D. · Eulji General Hospital

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

  • Donghyeok Shin, MD. Ph D. · Konkuk University Medical Center

  • Junhyeong Kim, MD. Ph D. · Keimyung University Dongsan Medical Center

  • Kang Chan, MD. Ph D. · Chungnam National University Hospital

  • Hyungmin Hahn, MD. Ph D. · Ajou University Medical Center

  • Changsik Park, MD. Ph D. · Seoul National University Bundang Hospital

  • Youngkoo Lee, MD. Ph D. · Soonchunhyang University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2019-12-09
Completion
2020-02-20

Countries

  • South Korea

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 NCT03370874 on ClinicalTrials.gov