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

Primary Purpose

Diabetic Foot Ulcer

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ALLO-ASC-DFU

Vehicle sheet

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is between 18 and 75 years of age.
Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
Foot ulcer size is between 1 cm2 and 15 cm2
Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
Free of necrotic debris at target ulcer
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
Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.

Exclusion Criteria:

Non-diabetic pathophysiologic ulcer.
The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
Subjects requiring intravenous (IV) antibiotics to treat infection.
Current evidence of infection including pus drainage from the wound site.
Subject has a glycated hemoglobin A1c (HbA1c) level of > 15%
Subject's blood sugar is > 450 mg/dl at postprandial.
Subjects with severe renal failure that cannot be managed by renal dialysis.
Subjects with severe hepatic deficiencies.
Subject is Human Immunodeficiency Virus (HIV) positive.
Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
Subject who is pregnant or breast-feeding.
Subjects who are unwilling to use an "effective" method of contraception during the study.
Subjects who have a clinically relevant history of alcohol or drugs abuse.
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 investigator.
Subjects who are considered not suitable for the study by investigator.
Subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
Subjects who are currently or are enrolled in another clinical study within 60 days of screening.
Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
Subjects not comply with off-loading procedure

Sites / Locations

Korea University Kuro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALLO-ASC-DFU

Vehicle Sheet

Arm Description

Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells

Hydrogel sheet without Allogenic mesenchymal stem cell

Outcomes

Primary Outcome Measures

Proportions of subjects who achieved complete wound closure

Secondary Outcome Measures

Time taken to complete wound closure between the two groups

Proportions of subjects who achieved complete wound closure

Proportions of subjects who achieved complete wound closure by the classification of Wagner Grade between the two groups

Change rates in wound size and depth compared to baseline between the two groups

cm^2

Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations

Full Information

NCT ID

NCT03370874

First Posted

November 28, 2017

Last Updated

August 24, 2023

Sponsor

Anterogen Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03370874

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

June 27, 2018 (Actual)

Primary Completion Date

December 9, 2019 (Actual)

Study Completion Date

February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anterogen Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALLO-ASC-DFU

Arm Type

Experimental

Arm Description

Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells

Arm Title

Vehicle Sheet

Arm Type

Placebo Comparator

Arm Description

Hydrogel sheet without Allogenic mesenchymal stem cell

Intervention Type

Biological

Intervention Name(s)

ALLO-ASC-DFU

Other Intervention Name(s)

Hydrogel sheet containing allogenic mesenchymal stem cells

Intervention Description

Application of ALLO-ASC-DFU sheet to diabetic foot ulcer

Intervention Type

Procedure

Intervention Name(s)

Vehicle sheet

Other Intervention Name(s)

Hydrogel sheet without Allogenic mesenchymal stem cell

Intervention Description

Application of Vehicle sheet to diabetic foot ulcer

Primary Outcome Measure Information:

Title

Proportions of subjects who achieved complete wound closure

Time Frame

During 12 weeks

Secondary Outcome Measure Information:

Title

Time taken to complete wound closure between the two groups

Time Frame

During 12 weeks

Title

Proportions of subjects who achieved complete wound closure

Time Frame

Follow up to 12 weeks

Title

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

Title

Change rates in wound size and depth compared to baseline between the two groups

Description

cm^2

Time Frame

During 12 weeks

Title

Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations

Time Frame

Follow up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is between 18 and 75 years of age. Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit. Foot ulcer size is between 1 cm2 and 15 cm2 Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue. Free of necrotic debris at target ulcer 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 Subject is able to give written informed consent prior to study start and to comply with the study requirements during study. Exclusion Criteria: Non-diabetic pathophysiologic ulcer. The ulcer has increased or decreased in size by 30% or more during one week after the screening visit. Subjects requiring intravenous (IV) antibiotics to treat infection. Current evidence of infection including pus drainage from the wound site. Subject has a glycated hemoglobin A1c (HbA1c) level of > 15% Subject's blood sugar is > 450 mg/dl at postprandial. Subjects with severe renal failure that cannot be managed by renal dialysis. Subjects with severe hepatic deficiencies. Subject is Human Immunodeficiency Virus (HIV) positive. Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue. Subject who is pregnant or breast-feeding. Subjects who are unwilling to use an "effective" method of contraception during the study. Subjects who have a clinically relevant history of alcohol or drugs abuse. 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 investigator. Subjects who are considered not suitable for the study by investigator. Subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ). Subjects who are currently or are enrolled in another clinical study within 60 days of screening. Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days. Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening. Subjects not comply with off-loading procedure

Overall Study Officials: