Diabetic Foot UlcerPhase 3NCT04569409

Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.

A Phase 3 study testing ALLO-ASC-DFU in people with Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 Foot Ulcer, compared to placebo therapy. Read more about this study

Who is it for?: Ages 19 to 75 years
Conditions the study is for: Diabetic Foot Ulcer
What is being tested?: ALLO-ASC-DFU
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: 5 sitesSouth Korea
Study dates: 14 Jul 2020to 5 Dec 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is between 19 and 75 years of age.
Subject is diagnosed with Type I or Type II diabetics.
Diabetic foot ulcer has been more than 4 weeks but less than 52 weeks at the screening visit.
Ulcer located in the foot and ulcer size is between 1.5~15 cm2.
Ulcer graded 2 by Wagner grade.
Foot ulcer extended to ligament, tendon, joint capsule, fascia, muscle and periosteum.

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Ulcer is free of necrotic debris.
Ulcer area blood circulation meets one of the following criteria;
Blood vessels around the ulcer detected by Doppler Test
Range of Ankle Brachial Index (ABI) is > 0.7 to < 1.3
Transcutaneous Oxygen Pressure (TcPO2) > 30mmHg or Toe Blood Pressure (TBP) > 40mmHg.
Skin Perfusion Pressure (SPP) > 30mmHg
Subject is able to give written informed consent prior to study start and willing to comply with the study requirements.

Who cannot join

Ulcer is of non-diabetic pathophysiology.
There is gangrene in any part of the target foot ulcer.
The longest dimension of the target foot ulcer exceeds 15 cm at the enrollment visit.
Other wounds within 2cm of the target foot ulcer.
The ulcer has increased or decreased in size by ≥ 30% during two weeks after the screening visit.
Patient requiring intravenous (IV) antibiotics to treat foot wound infection at the screening and enrollment visit.

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Current evidence of active charcot on the study foot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulent drainage from wound site.
Patient with skin lesion confirmed by biopsy (when Investigator deems suspicious) and then judged by Investigator to be an etiology other than diabetic foot ulcer.
An active malignant tumor(malignant melanoma, squamous cell carcinoma, basal cell carcinoma) on the body or skin.
Have a glycated hemoglobin A1c (HbA1c) level of > 14%
Have random blood sugar > 450mg/dL
Have severe renal failure with creatinine > 3.0mg/dL.
Have severe hepatic deficiencies
Total bilirubin ≥ 1.5×upper normal limit(UNL)
AST, ALT ≥ 2.0×UNL
Serum albumin < 2.0mg/dL
Is Human Immunodeficiency Virus (HIV) positive
Have a known history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue
Pregnant or breast-feeding.
Is unwilling to use an acceptable method of birth control during the whole study.
Have a clinically relevant history of alcohol or drugs abuse at the screening visit.
Is not able to understand the objective of the study or to comply with the study requirements
Is considered by the Investigator to have a significant disease which might impact the study
Is considered not suitable for the study by Investigator
Have a history of malignancy within the last 5 years (except carcinoma in situ)
Is currently or were enrolled in another clinical study within 60 days of screening
Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
Is receiving oral or parenteral corticosteroids, any immunosuppressive, or cytotoxic agents with unstable dose within the last 30 days
Cannot maintain off-loading process and device.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

South Korea5 sites

Bucheon ST. Mary's Hospital
Gyeonggi-do, Bucheon, 14647
Seoul National University Bundang Hospital
Gyeonggi-do, Seongnam-si, 13620
Asan Medical Center
Seoul, Seoul, 05505
Borame Medical Center
Seoul, Seoul, 07061
Korea University Guro Hospital
Seoul, Seoul, 08308

Other trials in South Korea

About this study

Official title: Phase 3 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers: A Randomized, Comparator-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 Wagner grade 2 Foot Ulcer, compared to placebo therapy.

Read the 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

Conditions: Diabetic Foot Ulcer
Being tested: ALLO-ASC-DFU, Vehicle Sheet
Medical subject headings: Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALLO-ASC-DFUBiological
Application of ALLO-ASC-DFU sheet to Diabetic Wagner grade 2 Foot Ulcer
Vehicle SheetProcedure or surgery
Application of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer

Study groups in NCT04569409
Study group	Role	What they receive
ALLO-ASC-DFU	Experimental	Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells Receives: Biological: ALLO-ASC-DFU
Vehicle sheet	Placebo comparator	Hydrogel sheet without allogenic mesenchymal stem cell Receives: Procedure: Vehicle Sheet

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportions of subjects who achieved complete wound closure
Measured: During 12 weeks

Secondary outcomes (3)

Time taken to complete wound closure
Measured: During 12 weeks
Proportions of subjects who achieved complete wound closure at every visit
Measured: During 12 weeks
Change rates in wound size and depth compared to baseline groups
Measured: During 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 20205 Dec 2024

First posted29 Sep 2020
Study start14 Jul 2020
Primary completion5 Dec 2024
Study completion5 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04569409
Sponsor's protocol ID: ALLO-ASC-DFU-302
Status last verified: Dec 2024
First submitted: 24 Sep 2020
Last updated: 22 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers: A Randomized, Comparator-controlled, Double-blind, Parallel-group, Multi-center Study
ClinicalTrials.gov ID: NCT04569409
Acronym / sponsor ID: ALLO-ASC-DFU-302
Conditions: Diabetic Foot Ulcer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Anterogen Co., Ltd.Industry (pharma, biotech, devices)
Study start: 14 Jul 2020 (actual)
Primary completion: 5 Dec 2024 (actual)
Study completion: 5 Dec 2024 (actual)
First posted: 29 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 Foot Ulcer, compared to placebo therapy.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ALLO-ASC-DFU	Experimental	Biological: ALLO-ASC-DFUHydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
Vehicle sheet	Placebo comparator	Procedure: Vehicle SheetHydrogel sheet without allogenic mesenchymal stem cell

Who may qualify

Ages: 19 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Subject is between 19 and 75 years of age.
Subject is diagnosed with Type I or Type II diabetics.
Diabetic foot ulcer has been more than 4 weeks but less than 52 weeks at the screening visit.
Ulcer located in the foot and ulcer size is between 1.5~15 cm2.
Ulcer graded 2 by Wagner grade.

Key exclusion criteria (29 listed)

Ulcer is of non-diabetic pathophysiology.
There is gangrene in any part of the target foot ulcer.
The longest dimension of the target foot ulcer exceeds 15 cm at the enrollment visit.
Other wounds within 2cm of the target foot ulcer.
The ulcer has increased or decreased in size by ≥ 30% during two weeks after the screening visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALLO-ASC-DFUApplication of ALLO-ASC-DFU sheet to Diabetic Wagner grade 2 Foot Ulcer	Biological	ALLO-ASC-DFU
Vehicle SheetApplication of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer	Procedure or surgery	Vehicle sheet

Primary outcome

Proportions of subjects who achieved complete wound closure
Time frame: During 12 weeks

3 secondary outcomes

Time taken to complete wound closure
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure at every visit
Time frame: During 12 weeks
Change rates in wound size and depth compared to baseline groups
Time frame: During 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Individual participant dataSharing planned: Undecided

Related trials for Diabetic Foot Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SeungKyu Han, MD. Ph D principal investigator

Korea University Guro Hospital

BaekKyu Kim, MD. Ph D principal investigator

Seoul National University Bundang Hospital

JunPio Hong, MD. Ph D principal investigator

Asan Medical Center

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALLO-ASC-DFU in people with Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 5 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportions of subjects who achieved complete wound closure (time frame: During 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04569409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.