Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-14

Study Completion Date

2024-12-05

Brief Summary

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This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 Foot Ulcer, compared to placebo therapy.

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Detailed Description

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Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double blind, Parallel-group, Multi-center Study

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ALLO-ASC-DFU

Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells

Group Type EXPERIMENTAL

ALLO-ASC-DFU

Intervention Type BIOLOGICAL

Application of ALLO-ASC-DFU sheet to Diabetic Wagner grade 2 Foot Ulcer

Vehicle sheet

Hydrogel sheet without allogenic mesenchymal stem cell

Group Type PLACEBO_COMPARATOR

Vehicle Sheet

Intervention Type PROCEDURE

Application of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer

Interventions

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ALLO-ASC-DFU

Application of ALLO-ASC-DFU sheet to Diabetic Wagner grade 2 Foot Ulcer

Intervention Type BIOLOGICAL

Vehicle Sheet

Application of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Subject is between 19 and 75 years of age.
2. Subject is diagnosed with Type I or Type II diabetics.
3. Diabetic foot ulcer has been more than 4 weeks but less than 52 weeks at the screening visit.
4. Ulcer located in the foot and ulcer size is between 1.5\~15 cm2.
5. Ulcer graded 2 by Wagner grade.
6. Foot ulcer extended to ligament, tendon, joint capsule, fascia, muscle and periosteum.
7. Ulcer is free of necrotic debris.
8. Ulcer area blood circulation meets one of the following criteria;

* Blood vessels around the ulcer detected by Doppler Test
* Range of Ankle Brachial Index (ABI) is \> 0.7 to \< 1.3
* Transcutaneous Oxygen Pressure (TcPO2) \> 30mmHg or Toe Blood Pressure (TBP) \> 40mmHg.
* Skin Perfusion Pressure (SPP) \> 30mmHg
9. Subject is able to give written informed consent prior to study start and willing to comply with the study requirements.

Exclusion Criteria

1. Ulcer is of non-diabetic pathophysiology.
2. There is gangrene in any part of the target foot ulcer.
3. The longest dimension of the target foot ulcer exceeds 15 cm at the enrollment visit.
4. Other wounds within 2cm of the target foot ulcer.
5. The ulcer has increased or decreased in size by ≥ 30% during two weeks after the screening visit.
6. Patient requiring intravenous (IV) antibiotics to treat foot wound infection at the screening and enrollment visit.
7. Current evidence of active charcot on the study foot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulent drainage from wound site.
8. Patient with skin lesion confirmed by biopsy (when Investigator deems suspicious) and then judged by Investigator to be an etiology other than diabetic foot ulcer.
9. An active malignant tumor(malignant melanoma, squamous cell carcinoma, basal cell carcinoma) on the body or skin.
10. Have a glycated hemoglobin A1c (HbA1c) level of \> 14%
11. Have random blood sugar \> 450mg/dL
12. Have severe renal failure with creatinine \> 3.0mg/dL.
13. Have severe hepatic deficiencies

* Total bilirubin ≥ 1.5×upper normal limit(UNL)
* AST, ALT ≥ 2.0×UNL
* Serum albumin \< 2.0mg/dL
14. Is Human Immunodeficiency Virus (HIV) positive
15. Have a known history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue
16. Pregnant or breast-feeding.
17. Is unwilling to use an acceptable method of birth control during the whole study.
18. Have a clinically relevant history of alcohol or drugs abuse at the screening visit.
19. Is not able to understand the objective of the study or to comply with the study requirements
20. Is considered by the Investigator to have a significant disease which might impact the study
21. Is considered not suitable for the study by Investigator
22. Have a history of malignancy within the last 5 years (except carcinoma in situ)
23. Is currently or were enrolled in another clinical study within 60 days of screening
24. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
25. Is receiving oral or parenteral corticosteroids, any immunosuppressive, or cytotoxic agents with unstable dose within the last 30 days
26. Cannot maintain off-loading process and device.

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No