Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers

January 21, 2025 updated by: Anterogen Co., Ltd.

A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers

This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, 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

  1. Active Group: ALLO-ASC-SHEET
  2. Control Group: Hydrogel SHEET (vehicle control)
  3. Study Type: Interventional
  4. Study Design: Randomized, Comparator-controlled, Double-blind, 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.
66

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 2

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: David G. Armstrong, MD.Ph D.
  • Phone Number: (+1)5203059393
  • Email: armstrong@usa.net

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects between 18 and 80 years of age.
  2. 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 located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2.
  4. Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule.
  5. Ulcer is free of necrotic debris, exhibits no signs of clinical infection.

  6. Ulcer area blood circulation meets one of the following criteria

    • A. Blood vessels around the ulcer detected by Doppler Test
    • B. range of Ankle Brachial Index(ABI) was > 0.7 to < 1.3
    • C. Transcutaneous oxygen pressure, (TcPO2) > 30 mmHg.
  7. Is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Ulcer is of non-diabetic pathophysiology.
  2. The ulcer has increased or decreased in size by ≥ 30% during the week after the Screening Visit.
  3. Is Human Immunodeficiency Virus (HIV) positive?
  4. Have severe hepatic deficiencies.
  5. Have a glycated hemoglobin A1c (HbA1c) level of > 10%.
  6. Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
  7. Require intravenous (IV) antibiotics to treat the target wound infection.
  8. Have severe renal failure including subject on renal dialysis.
  9. Pregnant or breast-feeding.
  10. Is unwilling to use an "effective" method of contraception during the study.
  11. Have evidence of current infection including pus drainage from the wound site.
  12. Have a clinically relevant history of alcohol or drugs abuse.
  13. Have postprandial blood sugar > 350 mg/dl.
  14. Is not able to understand the objective of this study or to comply with the study requirements.
  15. Is considered by the investigator to have a significant disease which might have impacted the study.
  16. Is considered not suitable for the study by investigator.
  17. Have a history of malignancy within the last five years (except basal cell carcinoam in situ).
  18. Is currently or were enrolled in another clinical study within 60 days of screening.
  19. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
  20. Is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
  21. Cannot maintain off-loading process
  22. Panel reactive antibody (PRA) levels ≥ 20%

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
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: Hydrogel SHEET(Vehicle control)
Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells
Procedure: Hydrogel SHEET(Vehicle control)
Application of Hydrogel SHEET to diabetic foot ulcer
Other Names:
  • Hydrogel sheet without Allogenic Mesenchymal Stem Cells

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
Measure Description
Time Frame
Proportions of subjects who achieved complete wound closure
Time Frame: During 12 weeks
Proportions of subjects who achieved complete wound closure
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 to initial complete wound closure between the two groups
Time Frame: During 12 weeks
Time to initial complete wound closure between the two groups
During 12 weeks
Changes in wound size compared to baseline between the two groups
Time Frame: During 12 weeks
Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)
During 12 weeks
Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, Plantar and the other location between the two groups
Time Frame: During 12 weeks(at every visit during treatment period)
Proportions of subjects who achieved complete wound closure
During 12 weeks(at every visit during treatment period)
Durability of complete wound closure
Time Frame: Follow up to 24 weeks from the initial complete wound closure.
Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)
Follow up to 24 weeks from the initial complete wound closure.

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: David G. Armstrong, MD.Ph D., University of Southern California
  • Principal Investigator: Alexander M. Reyzelman, DPM, Center for Clinical Research
  • Principal Investigator: Young Nathan, DPM, Martinsville Research Institute

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.
January 2, 2019

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.
October 23, 2023

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.
October 23, 2023

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 20, 2018

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.
November 25, 2018

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.
November 27, 2018

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.
March 25, 2025

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.
January 21, 2025

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.
January 1, 2025

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-SHEET-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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