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

NCT02619877 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2017-09-01

No results posted yet for this study

Summary

This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.

Conditions

  • Diabetic Foot Ulcer

Interventions

BIOLOGICAL

ALLO-ASC-DFU

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

OTHER

Standard therapy

Standard therapy conducted for patients with diabetic foot ulcer

Sponsors & Collaborators

  • Anterogen Co., Ltd.

    lead INDUSTRY

Principal Investigators

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

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

  • Hyun-suk Suh, MD. PhD. · Asan Medical Center

  • Jin Woo Lee, MD. PhD. · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-09-30
Completion
2016-10-31

Countries

  • South Korea

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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 NCT02619877 on ClinicalTrials.gov