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
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 13, 2017
CompletedStudy Start
First participant enrolled
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2020
CompletedAugust 25, 2023
August 1, 2023
1.5 years
November 28, 2017
August 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Proportions of subjects who achieved complete wound closure
During 12 weeks
Secondary Outcomes (5)
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
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
Study Arms (2)
ALLO-ASC-DFU
EXPERIMENTALHydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
Vehicle Sheet
PLACEBO COMPARATORHydrogel sheet without Allogenic mesenchymal stem cell
Interventions
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
Application of Vehicle sheet to diabetic foot ulcer
Eligibility Criteria
You may qualify if:
- Subject is between 18 and 75 years of age.
- Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
- Foot ulcer size is between 1 cm2 and 15 cm2
- Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
- Free of necrotic debris at target ulcer
- Around ulcer area blood circulation should be secured to meet one of below criteria;
- Blood vessels around the ulcer detected by Doppler Test
- \< Ankle Brachial Index(ABI) \< 1.3
- Transcutaneous Oxygen Pressure, TcPO2 higher than 30 mmHg
- Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.
You may not qualify if:
- Non-diabetic pathophysiologic ulcer.
- The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
- Subjects requiring intravenous (IV) antibiotics to treat infection.
- Current evidence of infection including pus drainage from the wound site.
- Subject has a glycated hemoglobin A1c (HbA1c) level of \> 15%
- Subject's blood sugar is \> 450 mg/dl at postprandial.
- Subjects with severe renal failure that cannot be managed by renal dialysis.
- Subjects with severe hepatic deficiencies.
- Subject is Human Immunodeficiency Virus (HIV) positive.
- Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
- Subject who is pregnant or breast-feeding.
- Subjects who are unwilling to use an "effective" method of contraception during the study.
- Subjects who have a clinically relevant history of alcohol or drugs abuse.
- Subjects who are not able to understand the objective of this study or to comply with the study requirements.
- Subjects who are considered to have a significant disease which can impact the study by investigator.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Kuro Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Donghyeok Shin, MD. Ph D.
Konkuk University Medical Center
- PRINCIPAL INVESTIGATOR
Junhyeong Kim, MD. Ph D.
Keimyung University Dongsan Medical Center
- PRINCIPAL INVESTIGATOR
Kang Chan, MD. Ph D.
Chungnam National University Hospital
- PRINCIPAL INVESTIGATOR
Hyungmin Hahn, MD. Ph D.
Ajou University Medical Center
- PRINCIPAL INVESTIGATOR
Changsik Park, MD. Ph D.
Seoul National University Bundang Hospital
- PRINCIPAL INVESTIGATOR
Youngkoo Lee, MD. Ph D.
Soonchunhyang University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 13, 2017
Study Start
June 27, 2018
Primary Completion
December 9, 2019
Study Completion
February 20, 2020
Last Updated
August 25, 2023
Record last verified: 2023-08