Diabetic Foot UlcerNCT06141811
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
An observational study of Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 4 sites in South Korea.
Trial 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-302) for 24 months 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
- How many people
- 104 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 25 Apr 2023to 31 Mar 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: ubjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
Who may be able to join
- Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
- Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- 1. Subjects who are considered not suitable for the study by the principal investigator.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Soonchunhyang University Hospital
Bucheon-si, Gyeonggi-do, 14584
YoungKoo Lee, MD. Ph D., +82 32 621 6705, brain0808@hanmail.net
- Recruiting
Bucheon ST. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
DaeWon Jun, MD. Ph D, +82 10 9405 6543, jundw430@gmail.com
- Recruiting
Asan Medical Center
Seoul, 05505
ChangSik Park, MD. Ph D, +82 2 3010 3600, iloveps.jcp@gmail.com
- Recruiting
Borame Medical Center
Seoul, 07061
JiUng Bak, MD. Ph D, +82 2 870 2332, alfbskan@gmail.com
About this study
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-302) for 24 months
Read the detailed description
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.
- 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 Foot Ulcer. This study is a follow-up study without intervention.
Vehicle sheetProcedure or surgery
Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
| Study group | Role | What they receive |
|---|---|---|
| ALLO-ASC-DFU | Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-302 Receives: Biological: ALLO-ASC-DFU | |
| Vehicle sheet | Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-302 Receives: Procedure: Vehicle sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of systemic tolerance through incidence of abnormal laboratory test results
Measured: Up to 9 months
Evaluation of incidence of clinically significant change in physical examination and vital signs
Measured: Up to 18 months
Evaluation of localized tolerance through incidence of clinically significant change about treatment area
Measured: Up to 24 months
Evaluation of incidence of adverse events
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start25 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ChangSik Park, MD. Ph D, Principal investigator, Asan Medical CenterJiUng Bak, MD. Ph D, Principal investigator, Borame Medical CenterDaeWon Jun, MD. Ph D, Principal investigator, Bucheon St. Mary's HospitalYoungKoo Lee, MD. Ph D, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141811
- Sponsor's protocol ID
- ALLO-ASC-DFU-304
- Status last verified
- Dec 2024
- First submitted
- 2 Nov 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
- ClinicalTrials.gov ID
- NCT06141811
- Acronym / sponsor ID
- ALLO-ASC-DFU-304
- Conditions
- Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Nov 2023 (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 follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months
Detailed description
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLO-ASC-DFU | – | Biological: ALLO-ASC-DFUSubjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-302 |
| Vehicle sheet | – | Procedure: Vehicle sheetSubjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-302 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ubjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
Key inclusion criteria (2 listed)
- Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
- Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.
Key exclusion criteria (1 listed)
- 1. Subjects who are considered not suitable for the study by the principal investigator.
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 Foot Ulcer. This study is a follow-up study without intervention. | Biological | ALLO-ASC-DFU |
| Vehicle sheetApplication of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention. | Procedure or surgery | Vehicle sheet |
Primary outcome
Evaluation of systemic tolerance through incidence of abnormal laboratory test results
Time frame: Up to 9 months
Evaluation of incidence of clinically significant change in physical examination and vital signs
Time frame: Up to 18 months
Evaluation of localized tolerance through incidence of clinically significant change about treatment area
Time frame: Up to 24 months
Evaluation of incidence of adverse events
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- 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.
ChangSik Park, MD. Ph D principal investigator
Asan Medical Center
JiUng Bak, MD. Ph D principal investigator
Borame Medical Center
DaeWon Jun, MD. Ph D principal investigator
Bucheon St. Mary's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 4 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ChangSik Park, MD. Ph D (+82 2 3010 3600, iloveps.jcp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of systemic tolerance through incidence of abnormal laboratory test results (time frame: Up to 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2024.