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

NCT04569409 | Completed Phase 3

• 1 other identifier: ALLO-ASC-DFU-302
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Proportions of subjects who achieved complete wound closure

  During 12 weeks

Secondary Outcomes (3)

• Time taken to complete wound closure

  During 12 weeks

• Proportions of subjects who achieved complete wound closure at every visit

  During 12 weeks

• Change rates in wound size and depth compared to baseline groups

  During 12 weeks

Study Arms (2)

ALLO-ASC-DFU

EXPERIMENTAL

Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells

Biological: ALLO-ASC-DFU

Vehicle sheet

PLACEBO COMPARATOR

Hydrogel sheet without allogenic mesenchymal stem cell

Procedure: Vehicle Sheet

Interventions

ALLO-ASC-DFU BIOLOGICAL

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

ALLO-ASC-DFU

Vehicle Sheet PROCEDURE

Application of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer

Vehicle sheet

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 19 and 75 years of age.
• Subject is diagnosed with Type I or Type II diabetics.
• Diabetic foot ulcer has been more than 4 weeks but less than 52 weeks at the screening visit.
• Ulcer located in the foot and ulcer size is between 1.5\~15 cm2.
• Ulcer graded 2 by Wagner grade.
• Foot ulcer extended to ligament, tendon, joint capsule, fascia, muscle and periosteum.
• Ulcer is free of necrotic debris.
• 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
• Subject is able to give written informed consent prior to study start and willing to comply with the study requirements.

You may not qualify if:

• Ulcer is of non-diabetic pathophysiology.
• There is gangrene in any part of the target foot ulcer.
• The longest dimension of the target foot ulcer exceeds 15 cm at the enrollment visit.
• Other wounds within 2cm of the target foot ulcer.
• The ulcer has increased or decreased in size by ≥ 30% during two weeks after the screening visit.
• Patient requiring intravenous (IV) antibiotics to treat foot wound infection at the screening and enrollment visit.
• Current evidence of active charcot on the study foot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulent drainage from wound site.
• 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.
• An active malignant tumor(malignant melanoma, squamous cell carcinoma, basal cell carcinoma) on the body or skin.
• Have a glycated hemoglobin A1c (HbA1c) level of \> 14%
• Have random blood sugar \> 450mg/dL
• Have severe renal failure with creatinine \> 3.0mg/dL.
• Have severe hepatic deficiencies
• Total bilirubin ≥ 1.5×upper normal limit(UNL)
• AST, ALT ≥ 2.0×UNL

Sponsors & Collaborators

• Anterogen Co., Ltd.: lead

Study Sites (5)

Bucheon ST. Mary's Hospital

Gyeonggi-do, Bucheon, 14647, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, Seongnam-si, 13620, South Korea

Location

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

Borame Medical Center

Seoul, Seoul, 07061, South Korea

Location

Korea University Guro Hospital

Seoul, Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• SeungKyu Han, MD. Ph D

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• BaekKyu Kim, MD. Ph D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• JunPio Hong, MD. Ph D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• JiUng Bak, MD. Ph D

  Borame Medical Center

  PRINCIPAL INVESTIGATOR

• YeongCheol Seo, MD. Ph D

  Bucheon St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

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: September 24, 2020
• First Posted: September 29, 2020
• Study Start: July 14, 2020
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: September 22, 2025

Record last verified: 2024-12

Locations

KR (5)