Clinical trial NCT04569409: Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.
Official title: Phase 3 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers: A Randomized, Comparator-controlled, Double-blind, Parallel-group, Multi-center Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diabetic Foot Ulcer
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-29
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 Foot Ulcer, compared to placebo therapy.

Detailed description: Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double blind, Parallel-group, Multi-center Study

Eligibility criteria: Inclusion Criteria:

1. Subject is between 19 and 75 years of age.
2. Subject is diagnosed with Type I or Type II diabetics.
3. Diabetic foot ulcer has been more than 4 weeks but less than 52 weeks at the screening visit.
4. Ulcer located in the foot and ulcer size is between 1.5\~15 cm2.
5. Ulcer graded 2 by Wagner grade.
6. Foot ulcer extended to ligament, tendon, joint capsule, fascia, muscle and periosteum.
7. Ulcer is free of necrotic debris.
8. Ulcer area blood circulation meets one of the following criteria;

   * Blood vessels around the ulcer detected by Doppler Test
   * Range of Ankle Brachial Index (ABI) is \> 0.7 to \< 1.3
   * Transcutaneous Oxygen Pressure (TcPO2) \> 30mmHg or Toe Blood Pressure (TBP) \> 40mmHg.
   * Skin Perfusion Pressure (SPP) \> 30mmHg
9. Subject is able to give written informed consent prior to study start and willing to comply with the study requirements.

Exclusion Criteria:

1. Ulcer is of non-diabetic pathophysiology.
2. There is gangrene in any part of the target foot ulcer.
3. The longest dimension of the target foot ulcer exceeds 15 cm at the enrollment visit.
4. Other wounds within 2cm of the target foot ulcer.
5. The ulcer has increased or decreased in size by ≥ 30% during two weeks after the screening visit.
6. Patient requiring intravenous (IV) antibiotics to treat foot wound infection at the screening and enrollment visit.
7. Current evidence of active charcot on the study foot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulent drainage from wound site.
8. 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.
9. An active malignant tumor(malignant melanoma, squamous cell carcinoma, basal cell carcinoma) on the body or skin.
10. Have a glycated hemoglobin A1c (HbA1c) level of \> 14%
11. Have random blood sugar \> 450mg/dL
12. Have severe renal failure with creatinine \> 3.0mg/dL.
13. Have severe hepatic deficiencies

    * Total bilirubin ≥ 1.5×upper normal limit(UNL)
    * AST, ALT ≥ 2.0×UNL
    * Serum albumin \< 2.0mg/dL
14. Is Human Immunodeficiency Virus (HIV) positive
15. Have a known history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue
16. Pregnant or breast-feeding.
17. Is unwilling to use an acceptable method of birth control during the whole study.
18. Have a clinically relevant history of alcohol or drugs abuse at the screening visit.
19. Is not able to understand the objective of the study or to comply with the study requirements
20. Is considered by the Investigator to have a significant disease which might impact the study
21. Is considered not suitable for the study by Investigator
22. Have a history of malignancy within the last 5 years (except carcinoma in situ)
23. Is currently or were enrolled in another clinical study within 60 days of screening
24. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
25. Is receiving oral or parenteral corticosteroids, any immunosuppressive, or cytotoxic agents with unstable dose within the last 30 days
26. Cannot maintain off-loading process and device.

Primary outcomes:
measure: Proportions of subjects who achieved complete wound closure
timeFrame: During 12 weeks
Secondary outcomes:
measure: Time taken to complete wound closure
timeFrame: During 12 weeks
measure: Proportions of subjects who achieved complete wound closure at every visit
timeFrame: During 12 weeks
measure: Change rates in wound size and depth compared to baseline groups
timeFrame: During 12 weeks
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Bucheon ST. Mary's Hospital
state: Bucheon
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Seongnam-si
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Borame Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: SeungKyu Han, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: BaekKyu Kim, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: JunPio Hong, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Borame Medical Center
name: JiUng Bak, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Bucheon St. Mary's Hospital
name: YeongCheol Seo, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
References: