Diabetic Foot UlcerNCT04590703
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial
An observational study of Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 8 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-301) 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
- 73 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 24 Jun 2020to 2 Jun 2023
- Phase
- Observational
- 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
Study population: Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.
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-301.
- 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
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Soonchunhyang University Hospital
Bucheon-si, Gyeonggi-do, 14584
Keimyung University Dongsan Medical Center
Daegu, Gyeongsangnam-do, 42601
Chungnam National University Hospital
Daejeon, Chungcheongnam-do
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
Asan Medical Center
Seoul, 05505
Korea University Guro Hospital
Seoul, 08308
Ajou University Medical Center
Suwon, Gyeonggi-do, 16499
About this study
Official title: A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 3 Clinical Trial of ALLO-ASC-DFU-301
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
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-301) 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-301 Receives: Biological: ALLO-ASC-DFU | |
| Vehicle sheet | Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-301 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 posted19 Oct 2020
- Study start24 Jun 2020
- Primary completion30 Sep 2021
- Study completion2 Jun 2023
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
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungKyu Han, MD. Ph D., Principal investigator, Korea University Guro HospitalKiWon Young, MD. Ph D., Principal investigator, Nowon Eulji Medical CenterJunPyo Hong, MD. Ph D., Principal investigator, Asan Medical CenterJunHyeong Kim, MD. Ph D., Principal investigator, Keimyung University Dongsan Medical CenterChan Kang, MD. Ph D., Principal investigator, Chungnam National University HospitalHyungMin Hahn, MD. Ph D., Principal investigator, Ajou University School of MedicineChanYeong Heo, MD. Ph D., Principal investigator, Seoul National University Bundang HospitalYoungKoo Lee, MD. Ph D., Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590703
- Sponsor's protocol ID
- ALLO-ASC-DFU-303
- Status last verified
- Aug 2023
- First submitted
- 28 Sep 2020
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 3 Clinical Trial of ALLO-ASC-DFU-301
- ClinicalTrials.gov ID
- NCT04590703
- Acronym / sponsor ID
- ALLO-ASC-DFU-303
- Conditions
- Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 19 Oct 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 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
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-301) 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
- Retrospective
- 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-301 |
| Vehicle sheet | – | Procedure: Vehicle sheetSubjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-301 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.
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-301.
- 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
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 25 Aug 2023.
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
KiWon Young, MD. Ph D. principal investigator
Nowon Eulji Medical Center
JunPyo Hong, MD. Ph D. principal investigator
Asan Medical Center
8 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 8 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: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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?
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 25 Aug 2023.