Diabetic Foot UlcerPhase 3NCT03370874
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.
A Phase 3 study testing ALLO-ASC-DFU in people with Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 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
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jun 2018to 20 Feb 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between 18 and 75 years of age.
- Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
- Foot ulcer size is between 1 cm2 and 15 cm2
- Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
- Free of necrotic debris at target ulcer
- Around ulcer area blood circulation should be secured to meet one of below criteria;
Show all 10Show fewer
- 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
- Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.
Who cannot join
- Non-diabetic pathophysiologic ulcer.
- The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
- Subjects requiring intravenous (IV) antibiotics to treat infection.
- Current evidence of infection including pus drainage from the wound site.
- Subject has a glycated hemoglobin A1c (HbA1c) level of > 15%
- Subject's blood sugar is > 450 mg/dl at postprandial.
Show all 21Show fewer
- Subjects with severe renal failure that cannot be managed by renal dialysis.
- Subjects with severe hepatic deficiencies.
- Subject is Human Immunodeficiency Virus (HIV) positive.
- Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
- Subject who is pregnant or breast-feeding.
- Subjects who are unwilling to use an "effective" method of contraception during the study.
- Subjects who have a clinically relevant history of alcohol or drugs abuse.
- Subjects who are not able to understand the objective of this study or to comply with the study requirements.
- Subjects who are considered to have a significant disease which can impact the study by investigator.
- Subjects who are considered not suitable for the study by investigator.
- Subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
- Subjects who are currently or are enrolled in another clinical study within 60 days of screening.
- Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
- Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
- Subjects not comply with off-loading procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
Also called Hydrogel sheet containing allogenic mesenchymal stem cells
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
Vehicle sheetProcedure or surgery
Also called Hydrogel sheet without Allogenic mesenchymal stem cell
Application of Vehicle sheet to diabetic foot ulcer
| 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 (5)
Time taken to complete wound closure between the two groups
Measured: During 12 weeks
Proportions of subjects who achieved complete wound closure
Measured: Follow up to 12 weeks
Proportions of subjects who achieved complete wound closure by the classification of Wagner Grade between the two groups
Measured: Follow up to 12 weeks
Change rates in wound size and depth compared to baseline between the two groups
cm^2
Measured: During 12 weeks
Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations
Measured: Follow up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start27 Jun 2018
- Primary completion9 Dec 2019
- Study completion20 Feb 2020
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung-Kyu Han, MD. Ph D., Principal investigator, Korea University Guro HospitalKi-Won Young, MD. Ph D., Principal investigator, Eulji General HospitalJunpyo Hong, MD. Ph D., Principal investigator, Asan Medical CenterDonghyeok Shin, MD. Ph D., Principal investigator, Konkuk University Medical CenterJunhyeong Kim, MD. Ph D., Principal investigator, Keimyung University Dongsan Medical CenterKang Chan, MD. Ph D., Principal investigator, Chungnam National University HospitalHyungmin Hahn, MD. Ph D., Principal investigator, Ajou University School of MedicineChangsik Park, MD. Ph D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370874
- Sponsor's protocol ID
- ALLO-ASC-DFU-301
- Status last verified
- Aug 2023
- First submitted
- 28 Nov 2017
- Last updated
- 25 Aug 2023
- 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 25 Aug 2023. 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 Foot Ulcers: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study
- ClinicalTrials.gov ID
- NCT03370874
- Acronym / sponsor ID
- ALLO-ASC-DFU-301
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 13 Dec 2017 (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 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
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is between 18 and 75 years of age.
- Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
- Foot ulcer size is between 1 cm2 and 15 cm2
- Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
- Free of necrotic debris at target ulcer
Key exclusion criteria (21 listed)
- Non-diabetic pathophysiologic ulcer.
- The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
- Subjects requiring intravenous (IV) antibiotics to treat infection.
- Current evidence of infection including pus drainage from the wound site.
- Subject has a glycated hemoglobin A1c (HbA1c) level of > 15%
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-DFUAlso: Hydrogel sheet containing allogenic mesenchymal stem cellsApplication of ALLO-ASC-DFU sheet to diabetic foot ulcer | Biological | ALLO-ASC-DFU |
| Vehicle sheetAlso: Hydrogel sheet without Allogenic mesenchymal stem cellApplication of Vehicle sheet to diabetic foot ulcer | Procedure or surgery | Vehicle Sheet |
Primary outcome
Proportions of subjects who achieved complete wound closure
Time frame: During 12 weeks
5 secondary outcomes
Time taken to complete wound closure between the two groups
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure
Time frame: 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
Change rates in wound size and depth compared to baseline between the two groups
Time frame: 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
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.
- 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.
Seung-Kyu Han, MD. Ph D. principal investigator
Korea University Guro Hospital
Ki-Won Young, MD. Ph D. principal investigator
Eulji General Hospital
Junpyo Hong, MD. Ph D. principal investigator
Asan Medical Center
1 site 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 1 site 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 10 inclusion and 21 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 1 site 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?
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.