Diabetic Foot UlcerPhase 2NCT02619877
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers
A Phase 2 study testing ALLO-ASC-DFU and Standard therapy in people with Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 4 sites in South Korea.
Trial summary
This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- ALLO-ASC-DFU and Standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Oct 2015to Oct 2016
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between 18 years and 80 years of age.
- Subject is diagnosed with Type I or Type II diabetes, and had defined as diabetic foot ulcers presence of wound for more than 4 weeks at the screening visit.
- Ulcer located the foot, and ulcer size is between 1 cm^2 and 25 cm^2.
- Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2).
- Ulcer is free of necrotic debris.
- Subjects had adequate circulation to ulcer as documented by one of the methods below:
Show all 10Show fewer
- Palpation of pulses around ulcer using Doppler exam
- Ankle Brachial index (ABI) values ranging between 0.7 and 1.3, or
- Transcutaneous Oxygen Pressure (TcPO2) > 30 mmHg.
- Subject is able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- Ulcer is of non-diabetic pathophysiology.
- The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
- Subject is Human Immunodeficiency Virus (HIV) positive.
- Subjects with severe hepatic deficiencies.
- Subjects with a glycated hemoglobin A1c (HbA1c) level of > 15%.
- Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
Show all 20Show fewer
- Subjects requiring intravenous (IV) antibiotics to treat the index wound infection.
- Subjects with severe renal deficiencies that is uncontrolled by dialysis
- Subjects who are pregnant or breast-feeding.
- Subjects who are unwilling to use an "effective" method of contraception during the study.
- Current evidence of severe infection including pus drainage from the wound site.
- Subjects who have a clinically relevant history of alcohol or drugs abuse.
- Subject's blood sugar is > 450 mg/dL at postprandial.
- 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 the investigator.
- Subjects who are considered not suitable for the study by the investigator.
- Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
- Subjects who are currently or were enrolled in another clinical study within 60 days of screening.
- Subjects who have undergone wound treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days.
- Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents to unstable dosage.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Korea University Guro Hospital
Guro-gu, Seoul, 08308
Eulji General Hospital
Nowon-Gu, Seoul, 01830
Severance Hospital
Seodaemun-Gu, Seoul, 03722
Asan medical center
Songpa-Gu, Seoul, 05505
About this study
Official title: Phase 2 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers: A Randomized, Comparator-controlled, Single-blind, Parallel-group, Multi-center Study
This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.
Read the detailed description
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, Standard therapy
- 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 Allogeneic mesenchymal stem cells
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
Standard therapyOther
Standard therapy conducted for patients with diabetic foot ulcer
| Study group | Role | What they receive |
|---|---|---|
| ALLO-ASC-DFU | Experimental | Allogeneic mesenchymal stem cells Receives: Biological: ALLO-ASC-DFU |
| Standard therapy | Active comparator | Standard therapy for patients with diabetic foot ulcer Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of re-epithelialization
Measured: During 8 weeks
Secondary outcomes (3)
Proportion of re-epithelialization
Measured: During 12 weeks
Time to re-epithelialization
Measured: During 12 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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 posted2 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung-Kyu Han, MD. PhD., Principal investigator, Korea University Guro HospitalKi-Won Young, MD. PhD., Principal investigator, Eulji General HospitalHyun-suk Suh, MD. PhD., Principal investigator, Asan Medical CenterJin Woo Lee, MD. PhD., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619877
- Sponsor's protocol ID
- ALLO-ASC-DFU-201
- Status last verified
- Nov 2015
- First submitted
- 30 Nov 2015
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Moon KC, Suh HS, Kim KB, Han SK, Young KW, Lee JW, Kim MH. Potential of Allogeneic Adipose-Derived Stem Cell-Hydrogel Complex for Treating Diabetic Foot Ulcers. Diabetes. 2019 Apr;68(4):837-846. doi: 10.2337/db18-0699. Epub 2019 Jan 24.
PubMed 30679183
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers: A Randomized, Comparator-controlled, Single-blind, Parallel-group, Multi-center Study
- ClinicalTrials.gov ID
- NCT02619877
- Acronym / sponsor ID
- ALLO-ASC-DFU-201
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Dec 2015 (estimated)
- 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 II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.
Detailed description
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLO-ASC-DFU | Experimental | Biological: ALLO-ASC-DFUAllogeneic mesenchymal stem cells |
| Standard therapy | Active comparator | Other: Standard therapyStandard therapy for patients with diabetic foot ulcer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is between 18 years and 80 years of age.
- Subject is diagnosed with Type I or Type II diabetes, and had defined as diabetic foot ulcers presence of wound for more than 4 weeks at the screening visit.
- Ulcer located the foot, and ulcer size is between 1 cm^2 and 25 cm^2.
- Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2).
- Ulcer is free of necrotic debris.
Key exclusion criteria (20 listed)
- Ulcer is of non-diabetic pathophysiology.
- The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
- Subject is Human Immunodeficiency Virus (HIV) positive.
- Subjects with severe hepatic deficiencies.
- Subjects with 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: Allogeneic mesenchymal stem cellsApplication of ALLO-ASC-DFU sheet to diabetic foot ulcer | Biological | ALLO-ASC-DFU |
| Standard therapyStandard therapy conducted for patients with diabetic foot ulcer | Other | Standard therapy |
Primary outcome
Proportion of re-epithelialization
Time frame: During 8 weeks
3 secondary outcomes
Proportion of re-epithelialization
Time frame: During 12 weeks
Time to re-epithelialization
Time frame: During 12 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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 1 Sep 2017.
- Derived from this study: PubMed 30679183Moon KC, Suh HS, Kim KB, Han SK, Young KW, Lee JW, Kim MH. Potential of Allogeneic Adipose-Derived Stem Cell-Hydrogel Complex for Treating Diabetic Foot Ulcers. Diabetes. 2019 Apr;68(4):837-846. doi: 10.2337/db18-0699. Epub 2019 Jan 24.
- 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. PhD. principal investigator
Korea University Guro Hospital
Ki-Won Young, MD. PhD. principal investigator
Eulji General Hospital
Hyun-suk Suh, MD. PhD. principal investigator
Asan Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALLO-ASC-DFU and Standard therapy in people with 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 10 inclusion and 20 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 1 Sep 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of re-epithelialization (time frame: During 8 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 NCT02619877, which also lists 1 linked publication.
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 1 Sep 2017.