Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04569409
• Other study ID #: ALLO-ASC-DFU-302
• Status: Recruiting
• Phase: Phase 3
• Start date: July 14, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: Anterogen Co., Ltd.
• Contact: SeungKyu Han, MD. Ph D
• Phone: +82-02-2626-3333
• Email: pshan[@]kumc.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Biological:
• ALLO-ASC-DFU
Application of ALLO-ASC-DFU sheet to Diabetic Wagner grade 2 Foot Ulcer

Procedure:
• Vehicle Sheet
Application of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer

Locations

Country	Name	City	State
Korea, Republic of	Bucheon ST. Mary's Hospital	Gyeonggi-do	Bucheon
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Borame Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportions of subjects who achieved complete wound closure		During 12 weeks
Secondary	Time taken to complete wound closure		During 12 weeks
Secondary	Proportions of subjects who achieved complete wound closure at every visit		During 12 weeks
Secondary	Change rates in wound size and depth compared to baseline groups		During 12 weeks