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

Phase 3 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study

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

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Biological: ALLO-ASC-DFU; Procedure: Vehicle sheet

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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Kuro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is between 18 and 75 years of age.
2. Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
3. Foot ulcer size is between 1 cm2 and 15 cm2
4. Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
5. Free of necrotic debris at target ulcer

6. Around ulcer area blood circulation should be secured to meet one of below criteria;

   • Blood vessels around the ulcer detected by Doppler Test
   • 0.7 < Ankle Brachial Index(ABI) < 1.3
   • Transcutaneous Oxygen Pressure, TcPO2 higher than 30 mmHg
7. Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.

Exclusion Criteria:

1. Non-diabetic pathophysiologic ulcer.
2. The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
3. Subjects requiring intravenous (IV) antibiotics to treat infection.
4. Current evidence of infection including pus drainage from the wound site.
5. Subject has a glycated hemoglobin A1c (HbA1c) level of > 15%
6. Subject's blood sugar is > 450 mg/dl at postprandial.
7. Subjects with severe renal failure that cannot be managed by renal dialysis.
8. Subjects with severe hepatic deficiencies.
9. Subject is Human Immunodeficiency Virus (HIV) positive.
10. Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
11. Subject who is pregnant or breast-feeding.
12. Subjects who are unwilling to use an "effective" method of contraception during the study.
13. Subjects who have a clinically relevant history of alcohol or drugs abuse.
14. Subjects who are not able to understand the objective of this study or to comply with the study requirements.
15. Subjects who are considered to have a significant disease which can impact the study by investigator.
16. Subjects who are considered not suitable for the study by investigator.
17. Subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
18. Subjects who are currently or are enrolled in another clinical study within 60 days of screening.
19. Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
20. Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
21. Subjects not comply with off-loading procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALLO-ASC-DFU; Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells	Biological: ALLO-ASC-DFU; Application of ALLO-ASC-DFU sheet to diabetic foot ulcer; Other Names: Hydrogel sheet containing allogenic mesenchymal stem cells
Placebo Comparator: Vehicle Sheet; Hydrogel sheet without Allogenic mesenchymal stem cell	Procedure: Vehicle sheet; Application of Vehicle sheet to diabetic foot ulcer; Other Names: Hydrogel sheet without Allogenic mesenchymal stem cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportions of subjects who achieved complete wound closure	During 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken to complete wound closure between the two groups		During 12 weeks
Proportions of subjects who achieved complete wound closure		Follow up to 12 weeks
Proportions of subjects who achieved complete wound closure by the classification of Wagner Grade between the two groups		Follow up to 12 weeks
Change rates in wound size and depth compared to baseline between the two groups	cm^2	During 12 weeks
Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations		Follow up to 12 weeks

Collaborators and Investigators

• Sponsor: Anterogen Co., Ltd.
• Investigators: Principal Investigator: Seung-Kyu Han, MD. Ph D., Korea University Guro Hospital; Principal Investigator: Ki-Won Young, MD. Ph D., Eulji General Hospital; Principal Investigator: Junpyo Hong, MD. Ph D., Asan Medical Center; Principal Investigator: Junhyeong Kim, MD. Ph D., Keimyung University Dongsan Medical Center; Principal Investigator: Hyungmin Hahn, MD. Ph D., Ajou University Medical Center; Principal Investigator: Youngkoo Lee, MD. Ph D., Soonchunhyang University Hospital; Principal Investigator: Donghyeok Shin, MD. Ph D., Konkuk University Medical Center; Principal Investigator: Kang Chan, MD. Ph D., Chungnam National University Hospital; Principal Investigator: Changsik Park, MD. Ph D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): December 9, 2019
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: ALLO-ASC-DFU-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No