Using ALLO-ASC-SHEET to treat diabetic foot ulcers

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 study is testing if a new treatment called ALLO-ASC-SHEET can help heal diabetic foot ulcers better than a placebo for adults aged 18 to 80.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Anterogen Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT04497805 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical study evaluates the efficacy and safety of ALLO-ASC-SHEET in patients with diabetic Wagner Grade II foot ulcers compared to a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the treatment or placebo. Eligible participants include adults aged 18 to 80 with specific ulcer characteristics, and the study aims to determine if the treatment can improve healing outcomes. Participants will be monitored for safety and effectiveness throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with Type I or Type II diabetes and Wagner Grade II foot ulcers that have persisted for more than 4 weeks.

Not a fit: Patients with non-diabetic foot ulcers or those whose ulcers have changed in size may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with diabetic foot ulcers.

How similar studies have performed: Other studies have shown promise in using similar advanced therapies for wound healing, but this specific approach is still being evaluated.

Eligibility criteria

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:

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

Where this trial is running

Los Angeles, California

• University of Southern California — Los Angeles, California, United States (Recruiting)

Study contacts

• Study coordinator: Yun Jung Choi, PM

Conditions Diabetic Foot Ulcer