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NCT03370874 | COMPLETED | Diabetic Foot Ulcer

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

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

Diabetic Foot Ulcer

Intervention/treatment

ALLO-ASC-DFU

Vehicle sheet

Phase

PHASE3

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
Estimated Enrollment : 150 participants
Masking : DOUBLE
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 : 2018-06-27
Estimated Primary Completion Date : 2019-12-09
Estimated Study Completion Date : 2020-02-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.

Location Details

NCT03370874

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Korea, Republic of,

Korea University Kuro Hospital

Seoul, Korea, Republic of,