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

August 24, 2023 updated by: Anterogen Co., Ltd.

Phase 3 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is between 18 and 75 years of age.
  2. Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
  3. Foot ulcer size is between 1 cm2 and 15 cm2
  4. Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
  5. Free of necrotic debris at target ulcer

  6. Around ulcer area blood circulation should be secured to meet one of below criteria;

    • Blood vessels around the ulcer detected by Doppler Test
    • 0.7 < Ankle Brachial Index(ABI) < 1.3
    • Transcutaneous Oxygen Pressure, TcPO2 higher than 30 mmHg
  7. Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.

Exclusion Criteria:

  1. Non-diabetic pathophysiologic ulcer.
  2. The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
  3. Subjects requiring intravenous (IV) antibiotics to treat infection.
  4. Current evidence of infection including pus drainage from the wound site.
  5. Subject has a glycated hemoglobin A1c (HbA1c) level of > 15%
  6. Subject's blood sugar is > 450 mg/dl at postprandial.
  7. Subjects with severe renal failure that cannot be managed by renal dialysis.
  8. Subjects with severe hepatic deficiencies.
  9. Subject is Human Immunodeficiency Virus (HIV) positive.
  10. Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
  11. Subject who is pregnant or breast-feeding.
  12. Subjects who are unwilling to use an "effective" method of contraception during the study.
  13. Subjects who have a clinically relevant history of alcohol or drugs abuse.
  14. Subjects who are not able to understand the objective of this study or to comply with the study requirements.
  15. Subjects who are considered to have a significant disease which can impact the study by investigator.
  16. Subjects who are considered not suitable for the study by investigator.
  17. Subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
  18. Subjects who are currently or are enrolled in another clinical study within 60 days of screening.
  19. Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
  20. Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
  21. Subjects not comply with off-loading procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALLO-ASC-DFU
Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
Biological: ALLO-ASC-DFU
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
Other Names:
  • Hydrogel sheet containing allogenic mesenchymal stem cells
Placebo Comparator: Vehicle Sheet
Hydrogel sheet without Allogenic mesenchymal stem cell
Procedure: Vehicle sheet
Application of Vehicle sheet to diabetic foot ulcer
Other Names:
  • Hydrogel sheet without Allogenic mesenchymal stem cell

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportions of subjects who achieved complete wound closure
Time Frame: During 12 weeks
During 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time taken to complete wound closure between the two groups
Time Frame: During 12 weeks
During 12 weeks
Proportions of subjects who achieved complete wound closure
Time Frame: Follow up to 12 weeks
Follow up to 12 weeks
Proportions of subjects who achieved complete wound closure by the classification of Wagner Grade between the two groups
Time Frame: Follow up to 12 weeks
Follow up to 12 weeks
Change rates in wound size and depth compared to baseline between the two groups
Time Frame: During 12 weeks
cm^2
During 12 weeks
Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations
Time Frame: Follow up to 12 weeks
Follow up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anterogen Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seung-Kyu Han, MD. Ph D., Korea University Guro Hospital
  • Principal Investigator: Ki-Won Young, MD. Ph D., Eulji General Hospital
  • Principal Investigator: Junpyo Hong, MD. Ph D., Asan Medical Center
  • Principal Investigator: Junhyeong Kim, MD. Ph D., Keimyung University Dongsan Medical Center
  • Principal Investigator: Hyungmin Hahn, MD. Ph D., Ajou University Medical Center
  • Principal Investigator: Youngkoo Lee, MD. Ph D., Soonchunhyang University Hospital
  • Principal Investigator: Donghyeok Shin, MD. Ph D., Konkuk University Medical Center
  • Principal Investigator: Kang Chan, MD. Ph D., Chungnam national university hospital
  • Principal Investigator: Changsik Park, MD. Ph D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALLO-ASC-DFU-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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