Diabetic Foot UlcerPhase 2NCT03754465
Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers
A Phase 2 study testing ALLO-ASC-DFU in people with Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 1 site in United States.
Trial summary
This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 23 Oct 2023
- 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
- Male or female subjects between 18 and 80 years of age.
- Diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
- Foot ulcer located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2.
- Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule.
- Ulcer is free of necrotic debris, exhibits no signs of clinical infection.
- Ulcer area blood circulation meets one of the following criteria
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- A. Blood vessels around the ulcer detected by Doppler Test
- B. range of Ankle Brachial Index(ABI) was > 0.7 to < 1.3
- C. Transcutaneous oxygen pressure, (TcPO2) > 30 mmHg.
- 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% during the week after the Screening Visit.
- Is Human Immunodeficiency Virus (HIV) positive?
- Have severe hepatic deficiencies.
- Have a glycated hemoglobin A1c (HbA1c) level of > 10%.
- Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
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- Require intravenous (IV) antibiotics to treat the target wound infection.
- Have severe renal failure including subject on renal dialysis.
- Pregnant or breast-feeding.
- Is unwilling to use an "effective" method of contraception during the study.
- Have evidence of current infection including pus drainage from the wound site.
- Have a clinically relevant history of alcohol or drugs abuse.
- Have postprandial blood sugar > 350 mg/dl.
- Is not able to understand the objective of this study or to comply with the study requirements.
- Is considered by the investigator to have a significant disease which might have impacted the study.
- Is considered not suitable for the study by investigator.
- Have a history of malignancy within the last five years (except basal cell carcinoam 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, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
- Cannot maintain off-loading process
- Panel reactive antibody (PRA) levels ≥ 20%
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers
This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.
Read the detailed description
- Active Group: ALLO-ASC-SHEET
- Control Group: Hydrogel SHEET (vehicle control)
- Study Type: Interventional
- Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- ALLO-ASC-DFU, Hydrogel SHEET(Vehicle control)
- 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
Hydrogel SHEET(Vehicle control)Procedure or surgery
Also called Hydrogel sheet without Allogenic Mesenchymal Stem Cells
Application of Hydrogel SHEET to diabetic foot ulcer
| Study group | Role | What they receive |
|---|---|---|
| ALLO-ASC-DFU | Experimental | Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells Receives: Biological: ALLO-ASC-DFU |
| Hydrogel SHEET(Vehicle control) | Placebo comparator | Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells Receives: Procedure: Hydrogel SHEET(Vehicle control) |
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
Proportions of subjects who achieved complete wound closure
Measured: During 12 weeks
Secondary outcomes (4)
Time to initial complete wound closure between the two groups
Time to initial complete wound closure between the two groups
Measured: During 12 weeks
Changes in wound size compared to baseline between the two groups
Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)
Measured: During 12 weeks
Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, Plantar and the other location between the two groups
Proportions of subjects who achieved complete wound closure
Measured: During 12 weeks(at every visit during treatment period)
Durability of complete wound closure
Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)
Measured: Follow up to 24 weeks from the initial complete wound closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start2 Jan 2019
- Primary completion23 Oct 2023
- Study completion23 Oct 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David G. Armstrong, MD.Ph D., Principal investigator, University of Southern CaliforniaAlexander M. Reyzelman, DPM, Principal investigator, Center for Clinical ResearchYoung Nathan, DPM, Principal investigator, Martinsville Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754465
- Sponsor's protocol ID
- ALLO-ASC-SHEET-102
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2018
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03754465
- Acronym / sponsor ID
- ALLO-ASC-SHEET-102
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 27 Nov 2018 (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 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.
Detailed description
- Active Group: ALLO-ASC-SHEET
- Control Group: Hydrogel SHEET (vehicle control)
- Study Type: Interventional
- Study Design: Randomized, Comparator-controlled, Double-blind, 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-DFUExperimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells |
| Hydrogel SHEET(Vehicle control) | Placebo comparator | Procedure: Hydrogel SHEET(Vehicle control)Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects between 18 and 80 years of age.
- Diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
- Foot ulcer located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2.
- Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule.
- Ulcer is free of necrotic debris, exhibits no signs of clinical infection.
Key exclusion criteria (22 listed)
- Ulcer is of non-diabetic pathophysiology.
- The ulcer has increased or decreased in size by ≥ 30% during the week after the Screening Visit.
- Is Human Immunodeficiency Virus (HIV) positive?
- Have severe hepatic deficiencies.
- Have a glycated hemoglobin A1c (HbA1c) level of > 10%.
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 |
| Hydrogel SHEET(Vehicle control)Also: Hydrogel sheet without Allogenic Mesenchymal Stem CellsApplication of Hydrogel SHEET to diabetic foot ulcer | Procedure or surgery | Hydrogel SHEET(Vehicle control) |
Primary outcome
Proportions of subjects who achieved complete wound closure
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure
4 secondary outcomes
Time to initial complete wound closure between the two groups
Time frame: During 12 weeks
Changes in wound size compared to baseline between the two groups
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, Plantar and the other location between the two groups
Time frame: During 12 weeks(at every visit during treatment period)
Durability of complete wound closure
Time frame: Follow up to 24 weeks from the initial complete wound closure.
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 23 Jan 2025.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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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.
David G. Armstrong, MD.Ph D. principal investigator
University of Southern California
Alexander M. Reyzelman, DPM principal investigator
Center for Clinical Research
Young Nathan, DPM principal investigator
Martinsville Research Institute
1 site 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 in people with Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 1 site in United States.
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 22 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 23 Jan 2025. 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 United States. 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 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?
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 23 Jan 2025.