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

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ClinicalTrials.gov Identifier: NCT03370874
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Biological: ALLO-ASC-DFU Procedure: Vehicle sheet Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 4, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Hydrogel sheet without Allogenic mesenchymal stem cell




Primary Outcome Measures :
  1. Proportions of subjects who achieved complete wound closure [ Time Frame: During 12 weeks ]

Secondary Outcome Measures :
  1. Time taken to complete wound closure between the two groups [ Time Frame: During 12 weeks ]
  2. Proportions of subjects who achieved complete wound closure [ Time Frame: Follow up to 12 weeks ]
  3. Proportions of subjects who achieved complete wound closure by the classification of Wagner Grade between the two groups [ Time Frame: Follow up to 12 weeks ]
  4. Change rates in wound size and depth compared to baseline between the two groups [ Time Frame: During 12 weeks ]
    cm^2

  5. Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations [ Time Frame: Follow up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370874


Contacts
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Contact: Seung-Kyu Han, MD. Ph D. 82-2-2626-3333 pshan@kumc.or.kr

Locations
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Korea, Republic of
Korea University Kuro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung-Kyu Han         
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
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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: Chan Kang, MD. Ph D. Chungnam National University Hospital
Principal Investigator: Iljae Lee, MD. Ph D. Ajou University
Principal Investigator: Changsik Park, MD. Ph D. Seoul National University Bundang Hospital

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Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT03370874     History of Changes
Other Study ID Numbers: ALLO-ASC-DFU-301
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases