NCT04590703

Brief Summary

This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

September 28, 2020

Last Update Submit

August 24, 2023

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (4)

  • Evaluation of systemic tolerance through incidence of abnormal laboratory test results

    Up to 9 months

  • Evaluation of incidence of clinically significant change in physical examination and vital signs

    Up to 18 months

  • Evaluation of localized tolerance through incidence of clinically significant change about treatment area

    Up to 24 months

  • Evaluation of incidence of adverse events

    Up to 24 months

Study Arms (2)

ALLO-ASC-DFU

Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-301

Biological: ALLO-ASC-DFU

Vehicle sheet

Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-301

Procedure: Vehicle sheet

Interventions

ALLO-ASC-DFUBIOLOGICAL

Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.

ALLO-ASC-DFU
Vehicle sheetPROCEDURE

Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.

Vehicle sheet

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.

You may qualify if:

  • Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.
  • Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

You may not qualify if:

  • \. Subjects who are considered not suitable for the study by the principal investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

Location

Soonchunhyang University Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Ajou University Medical Center

Suwon, Gyeonggi-do, 16499, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, Gyeongsangnam-do, 42601, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • SeungKyu Han, MD. Ph D.

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

  • KiWon Young, MD. Ph D.

    Nowon Eulji Medical Center, Eulji University

    PRINCIPAL INVESTIGATOR

  • JunPyo Hong, MD. Ph D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • JunHyeong Kim, MD. Ph D.

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

  • Chan Kang, MD. Ph D.

    Chungnam National University Hospital

    PRINCIPAL INVESTIGATOR

  • HyungMin Hahn, MD. Ph D.

    Ajou University Medical Center

    PRINCIPAL INVESTIGATOR

  • ChanYeong Heo, MD. Ph D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

  • YoungKoo Lee, MD. Ph D.

    Soonchunhyang University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 19, 2020

Study Start

June 24, 2020

Primary Completion

September 30, 2021

Study Completion

June 2, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

KR(8)