Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers
Phase 2 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers: A Randomized, Comparator-controlled, Single-blind, Parallel-group, Multi-center Study
1 other identifier
interventional
59
1 country
4
Brief Summary
This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2015
Shorter than P25 for phase_2
4 active sites
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
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 30, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedSeptember 1, 2017
November 1, 2015
11 months
November 30, 2015
August 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of re-epithelialization
During 8 weeks
Secondary Outcomes (3)
Proportion of re-epithelialization
During 12 weeks
Time to re-epithelialization
During 12 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Follow up to 12 weeks
Study Arms (2)
ALLO-ASC-DFU
EXPERIMENTALAllogeneic mesenchymal stem cells
Standard therapy
ACTIVE COMPARATORStandard therapy for patients with diabetic foot ulcer
Interventions
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
Standard therapy conducted for patients with diabetic foot ulcer
Eligibility Criteria
You may qualify if:
- Subject is between 18 years and 80 years of age.
- Subject is diagnosed with Type I or Type II diabetes, and had defined as diabetic foot ulcers presence of wound for more than 4 weeks at the screening visit.
- Ulcer located the foot, and ulcer size is between 1 cm\^2 and 25 cm\^2.
- Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2).
- Ulcer is free of necrotic debris.
- Subjects had adequate circulation to ulcer as documented by one of the methods below:
- Palpation of pulses around ulcer using Doppler exam
- Ankle Brachial index (ABI) values ranging between 0.7 and 1.3, or
- Transcutaneous Oxygen Pressure (TcPO2) \> 30 mmHg.
- Subject is able to give written informed consent prior to study start and to comply with the study requirements.
You may not qualify if:
- Ulcer is of non-diabetic pathophysiology.
- The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
- Subject is Human Immunodeficiency Virus (HIV) positive.
- Subjects with severe hepatic deficiencies.
- Subjects with a glycated hemoglobin A1c (HbA1c) level of \> 15%.
- Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
- Subjects requiring intravenous (IV) antibiotics to treat the index wound infection.
- Subjects with severe renal deficiencies that is uncontrolled by dialysis
- Subjects who are pregnant or breast-feeding.
- Subjects who are unwilling to use an "effective" method of contraception during the study.
- Current evidence of severe infection including pus drainage from the wound site.
- Subjects who have a clinically relevant history of alcohol or drugs abuse.
- Subject's blood sugar is \> 450 mg/dL at postprandial.
- 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 the investigator.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Korea University Guro Hospital
Guro-gu, Seoul, 08308, South Korea
Eulji General Hospital
Nowon-Gu, Seoul, 01830, South Korea
Severance Hospital
Seodaemun-Gu, Seoul, 03722, South Korea
Asan medical center
Songpa-Gu, Seoul, 05505, South Korea
Related Publications (1)
Moon KC, Suh HS, Kim KB, Han SK, Young KW, Lee JW, Kim MH. Potential of Allogeneic Adipose-Derived Stem Cell-Hydrogel Complex for Treating Diabetic Foot Ulcers. Diabetes. 2019 Apr;68(4):837-846. doi: 10.2337/db18-0699. Epub 2019 Jan 24.
PMID: 30679183DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Kyu Han, MD. PhD.
Korea University Guro Hospital
- PRINCIPAL INVESTIGATOR
Ki-Won Young, MD. PhD.
Eulji General Hospital
- PRINCIPAL INVESTIGATOR
Hyun-suk Suh, MD. PhD.
Asan Medical Center
- PRINCIPAL INVESTIGATOR
Jin Woo Lee, MD. PhD.
Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2015
First Posted
December 2, 2015
Study Start
October 1, 2015
Primary Completion
September 1, 2016
Study Completion
October 1, 2016
Last Updated
September 1, 2017
Record last verified: 2015-11