Diabetic Foot UlcerPhase 2NCT04497805
Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers
A Phase 2 study testing ALLO-ASC-SHEET 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 Wagner Grade II 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-SHEET
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to Jun 2025
- 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 between 18 and 80 years of age.
- Diagnosed with Type I or Type II diabetes and has Wagner Grade II diabetic foot ulcers for longer than 4 weeks at the time of screening.
- Foot ulcer located in the plantar or dorsal, with ulcer size between1.5 cm2 and 15 cm2.
- Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon, or joint capsule, but not to bone.
- Ulcer is free of necrotic debris,exhibits no signs of clinical infection.
- Ulcer area blood circulation meets 1 of the following criteria:
- Blood vessels around the ulcer detected by Doppler Test to have biphasic or triphasic flow B. Range of Ankle Brachial Index(ABI) is>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 2 weeks screening period.
- Patient is currently on higher dose antibiotic therapy as defined by increased dose or change in therapy from the initial treatment regimen at screening to treat index wound infection or patient is on suppressive antibiotic therapy for diabetic foot wound infection.
- The longest dimension of the index wound exceeds 15 cm at the baseline visit.
- Patient with skin lesion confirmed by biopsy (when Investigator deems suspicious) and then judged by Investigator to be an etiology other than diabetic foot ulcer (i.e.,example skin cancer in situ, pyoderma).
- Current evidence of active charcot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulentdrainage from wound site.
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- Is Human Immunodeficiency Virus (HIV) positive
- Havesevere hepatic deficiencies.
- Have a glycated hemoglobin A1c (HbA1c) level of >10%.
- Have an allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
- Have severe renal function insufficiency documented with creatinine greater than 3.0 mg/dL.
- Pregnant or breast-feeding.
- Is unwilling to use an "effective" method of contraception during the study.
- Have evidence of current infection including purulent drainage from the wound site.
- Have a clinically relevant history of alcohol or drugs abuse.
- Have postprandialblood sugar >350 mg/dL at screening.
- Is not able to comply with the study requirements.
- Is considered by the Investigator to have a significant disease which might impact the study.
- Is considered not suitable for the study by Investigator.
- Have a history of malignancy within the last 5 years (except basal cell carcinoma 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 (In doses greater than 10 mg per day), any immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
- Cannot maintain off-loading process.
- Panel reactive antibody (PRA) levels ≥ 20% at screening.
- Venereal Disease Research Laboratory test (VDRL) or RPR positive
Trial locations and contacts
1 site in 1 country.
Jessi Choi, PM contact
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90033
David Armstrong, MD
About this study
Official title: A Phase 2 Clinical Study to Evaluate The Efficacy and Safety of ALLO-ASC-SHEET in the Subjects With Diabetic Wagner Grade II 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 Wagner Grade II Foot Ulcers, compared to placebo therapy.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- ALLO-ASC-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-SHEETBiological
Also called Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
| Study group | Role | What they receive |
|---|---|---|
| ALLO-ASC-SHEET | Experimental | ALLO-ASC-SHEET Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells Receives: Biological: ALLO-ASC-SHEET |
| Hydrogel SHEET(Vehicle control) | Placebo comparator | Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells Receives: Biological: ALLO-ASC-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.
Proportions of subjects who achieved complete wound closure during the 12 weeks.
Measured: During 12 weeks
Secondary outcomes (5)
Time to initial complete wound closure between the 2 groups.
Measure the time to initial complete wound closure between the 2 groups.
Measured: During 12 weeks
Changes in wound size compared to baseline between the 2 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 between the 2 groups by the classification of wound size.
Proportions of subjects who achieved complete wound closure by the classification of wound size, 1.5~7 cm2 and 7.1~15 cm2 between the 2 groups at every visit.
Measured: During 12 weeks
Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of location of diabetic foot ulcer.
Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, plantar and dorsal between the 2 groups at every visit by post-hoc analysis.
Measured: During 12 weeks
Durability of complete wound closure for the additional 24 weeks.
Durability of complete wound closure for the additional 24 weeks from the initial complete wound closure.
Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices).
Measured: During 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start8 Sep 2020
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Jung Choi, PM, Study director, Anterogen Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497805
- Sponsor's protocol ID
- ALLO-ASC-SHEET
- Status last verified
- Aug 2023
- First submitted
- 15 May 2020
- Last updated
- 24 Aug 2023
- Results posted
- No
- 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 24 Aug 2023. 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 the Subjects With Diabetic Wagner Grade II Foot Ulcers
- ClinicalTrials.gov ID
- NCT04497805
- Acronym / sponsor ID
- ALLO-ASC-SHEET
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 4 Aug 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 phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Wagner Grade II Foot Ulcers, compared to placebo therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLO-ASC-SHEET | Experimental | Biological: ALLO-ASC-SHEETALLO-ASC-SHEET Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells |
| Hydrogel SHEET(Vehicle control) | Placebo comparator | Biological: ALLO-ASC-SHEETVehicle 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 (8 listed)
- Male or female between 18 and 80 years of age.
- Diagnosed with Type I or Type II diabetes and has Wagner Grade II diabetic foot ulcers for longer than 4 weeks at the time of screening.
- Foot ulcer located in the plantar or dorsal, with ulcer size between1.5 cm2 and 15 cm2.
- Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon, or joint capsule, but not to bone.
- Ulcer is free of necrotic debris,exhibits no signs of clinical infection.
Key exclusion criteria (26 listed)
- Ulcer is of non-diabetic pathophysiology.
- The ulcer has increased or decreased in size by ≥30% during 2 weeks screening period.
- Patient is currently on higher dose antibiotic therapy as defined by increased dose or change in therapy from the initial treatment regimen at screening to treat index wound infection or patient is on suppressive antibiotic therapy for diabetic foot wound infection.
- The longest dimension of the index wound exceeds 15 cm at the baseline visit.
- Patient with skin lesion confirmed by biopsy (when Investigator deems suspicious) and then judged by Investigator to be an etiology other than diabetic foot ulcer (i.e.,example skin cancer in situ, pyoderma).
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-SHEETAlso: Hydrogel sheet containing Allogenic Mesenchymal Stem CellsHydrogel sheet containing Allogenic Mesenchymal Stem Cells | Biological | ALLO-ASC-SHEET, 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 during the 12 weeks.
5 secondary outcomes
Time to initial complete wound closure between the 2 groups.
Time frame: During 12 weeks
Changes in wound size compared to baseline between the 2 groups.
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of wound size.
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of location of diabetic foot ulcer.
Time frame: During 12 weeks
Durability of complete wound closure for the additional 24 weeks.
Time frame: During 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Jessi Choi, PM contact
Yun Jung Choi, PM study director
Anterogen Co., Ltd.
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-SHEET 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 8 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 24 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Jung Choi, PM (82 10 9199 0164, yunjungchoi@anterogen.com), or a site near the patient. 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 24 Aug 2023.