CClinicalTrials.gg
RecruitingNCT04497805Updated Aug 24, 2023

Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers

A Phase 2 interventional study of ALLO-ASC-SHEET in Diabetic Foot Ulcer, sponsored by Anterogen Co., Ltd.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-24.

Sponsored by Anterogen Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Sep 2020; still recruiting 6 years 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Foot Ulcer
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 64 is close to the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Anterogen Co., Ltd. is the lead sponsor of 30 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female between 18 and 80 years of age.
  2. 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.
  3. Foot ulcer located in the plantar or dorsal, with ulcer size between1.5 cm2 and 15 cm2.
  4. Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon, or joint capsule, but not to bone.
  5. Ulcer is free of necrotic debris,exhibits no signs of clinical infection.
  6. Ulcer area blood circulation meets 1 of the following criteria:

    A. 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.

  7. Is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion criteria

Exclusion Criteria:

  1. Ulcer is of non-diabetic pathophysiology.
  2. The ulcer has increased or decreased in size by ≥30% during 2 weeks screening period.
  3. 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.
  4. The longest dimension of the index wound exceeds 15 cm at the baseline visit.
  5. 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).
  6. Current evidence of active charcot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulentdrainage from wound site.
  7. Is Human Immunodeficiency Virus (HIV) positive
  8. Havesevere hepatic deficiencies.
  9. Have a glycated hemoglobin A1c (HbA1c) level of >10%.
  10. Have an allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
  11. Have severe renal function insufficiency documented with creatinine greater than 3.0 mg/dL.
  12. Pregnant or breast-feeding.
  13. Is unwilling to use an "effective" method of contraception during the study.
  14. Have evidence of current infection including purulent drainage from the wound site.
  15. Have a clinically relevant history of alcohol or drugs abuse.
  16. Have postprandialblood sugar >350 mg/dL at screening.
  17. Is not able to comply with the study requirements.
  18. Is considered by the Investigator to have a significant disease which might impact the study.
  19. Is considered not suitable for the study by Investigator.
  20. Have a history of malignancy within the last 5 years (except basal cell carcinoma in situ).
  21. Is currently or were enrolled in another clinical study within 60 days of screening.
  22. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
  23. 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.
  24. Cannot maintain off-loading process.
  25. Panel reactive antibody (PRA) levels ≥ 20% at screening.
  26. Venereal Disease Research Laboratory test (VDRL) or RPR positive
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    ALLO-ASC-SHEET

    ALLO-ASC-SHEET Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells

    Biological: ALLO-ASC-SHEET

  • Placebo comparator
    Hydrogel SHEET(Vehicle control)

    Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells

    Biological: ALLO-ASC-SHEET

Interventions

  • BiologicalALLO-ASC-SHEET

    Hydrogel sheet containing Allogenic Mesenchymal Stem Cells

    Also known as: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells

06

What researchers measure

Primary outcomes

  1. Proportions of subjects who achieved complete wound closure.

    Proportions of subjects who achieved complete wound closure during the 12 weeks.

    Time frame: During 12 weeks

Secondary outcomes

  1. Time to initial complete wound closure between the 2 groups.

    Measure the time to initial complete wound closure between the 2 groups.

    Time frame: During 12 weeks

  2. Changes in wound size compared to baseline between the 2 groups.

    Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices).

    Time frame: During 12 weeks

  3. 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.

    Time frame: During 12 weeks

  4. 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.

    Time frame: During 12 weeks

  5. 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).

    Time frame: During 36 weeks

07

Study locations

1 of 1 sites recruiting
  • University of Southern California
    Los Angeles, California 90033, United States
    • David Armstrong, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04497805
Lead sponsor
Anterogen Co., Ltd.
Responsible party
Sponsor
First posted
Aug 4, 2020
Start date
Sep 8, 2020
Primary completion
Dec 2024 (estimated)
Completion
Jun 2025 (estimated)
Last update
Aug 24, 2023

Study contacts

Yun Jung Choi, PM
Contact
yunjungchoi@anterogen.com
82 10 9199 0164
Jessi Choi, PM
Contact
82 10 9199 0164
Yun Jung Choi, PM
study director · Anterogen Co., Ltd.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion