RECRUITING

Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Wagner Grade II Foot Ulcers, compared to placebo therapy.

Official Title

A Phase 2 Clinical Study to Evaluate The Efficacy and Safety of ALLO-ASC-SHEET in the Subjects With Diabetic Wagner Grade II Foot Ulcers

Quick Facts

Study Start:2020-09-08

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04497805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female between 18 and 80 years of age. 2. Diagnosed with Type I or Type II diabetes and has Wagner Grade II diabetic foot ulcers for longer than 4 weeks at the time of screening. 3. Foot ulcer located in the plantar or dorsal, with ulcer size between1.5 cm2 and 15 cm2. 4. Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon, or joint capsule, but not to bone. 5. Ulcer is free of necrotic debris,exhibits no signs of clinical infection. 6. Ulcer area blood circulation meets 1 of the following criteria: 7. Is able to give written informed consent prior to study start and to comply with the study requirements.	1. Ulcer is of non-diabetic pathophysiology. 2. The ulcer has increased or decreased in size by ≥30% during 2 weeks screening period. 3. Patient is currently on higher dose antibiotic therapy as defined by increased dose or change in therapy from the initial treatment regimen at screening to treat index wound infection or patient is on suppressive antibiotic therapy for diabetic foot wound infection. 4. The longest dimension of the index wound exceeds 15 cm at the baseline visit. 5. 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 (i.e.,example skin cancer in situ, pyoderma). 6. Current evidence of active charcot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulentdrainage from wound site. 7. Is Human Immunodeficiency Virus (HIV) positive 8. Havesevere hepatic deficiencies. 9. Have a glycated hemoglobin A1c (HbA1c) level of \>10%. 10. Have an allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue. 11. Have severe renal function insufficiency documented with creatinine greater than 3.0 mg/dL. 12. Pregnant or breast-feeding. 13. Is unwilling to use an "effective" method of contraception during the study. 14. Have evidence of current infection including purulent drainage from the wound site. 15. Have a clinically relevant history of alcohol or drugs abuse. 16. Have postprandialblood sugar \>350 mg/dL at screening. 17. Is not able to comply with the study requirements. 18. Is considered by the Investigator to have a significant disease which might impact the study. 19. Is considered not suitable for the study by Investigator. 20. Have a history of malignancy within the last 5 years (except basal cell carcinoma in situ). 21. Is currently or were enrolled in another clinical study within 60 days of screening. 22. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days. 23. Is receiving oral or parenteral corticosteroids (In doses greater than 10 mg per day), any immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening. 24. Cannot maintain off-loading process. 25. Panel reactive antibody (PRA) levels ≥ 20% at screening. 26. Venereal Disease Research Laboratory test (VDRL) or RPR positive

Inclusion Criteria

Exclusion Criteria

1. Male or female between 18 and 80 years of age.
2. Diagnosed with Type I or Type II diabetes and has Wagner Grade II diabetic foot ulcers for longer than 4 weeks at the time of screening.
3. Foot ulcer located in the plantar or dorsal, with ulcer size between1.5 cm2 and 15 cm2.
4. Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon, or joint capsule, but not to bone.
5. Ulcer is free of necrotic debris,exhibits no signs of clinical infection.
6. Ulcer area blood circulation meets 1 of the following criteria:
7. Is able to give written informed consent prior to study start and to comply with the study requirements.

1. Ulcer is of non-diabetic pathophysiology.
2. The ulcer has increased or decreased in size by ≥30% during 2 weeks screening period.
3. Patient is currently on higher dose antibiotic therapy as defined by increased dose or change in therapy from the initial treatment regimen at screening to treat index wound infection or patient is on suppressive antibiotic therapy for diabetic foot wound infection.
4. The longest dimension of the index wound exceeds 15 cm at the baseline visit.
5. 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 (i.e.,example skin cancer in situ, pyoderma).
6. Current evidence of active charcot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulentdrainage from wound site.
7. Is Human Immunodeficiency Virus (HIV) positive
8. Havesevere hepatic deficiencies.
9. Have a glycated hemoglobin A1c (HbA1c) level of \>10%.
10. Have an allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
11. Have severe renal function insufficiency documented with creatinine greater than 3.0 mg/dL.
12. Pregnant or breast-feeding.
13. Is unwilling to use an "effective" method of contraception during the study.
14. Have evidence of current infection including purulent drainage from the wound site.
15. Have a clinically relevant history of alcohol or drugs abuse.
16. Have postprandialblood sugar \>350 mg/dL at screening.
17. Is not able to comply with the study requirements.
18. Is considered by the Investigator to have a significant disease which might impact the study.
19. Is considered not suitable for the study by Investigator.
20. Have a history of malignancy within the last 5 years (except basal cell carcinoma in situ).
21. Is currently or were enrolled in another clinical study within 60 days of screening.
22. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
23. Is receiving oral or parenteral corticosteroids (In doses greater than 10 mg per day), any immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
24. Cannot maintain off-loading process.
25. Panel reactive antibody (PRA) levels ≥ 20% at screening.
26. Venereal Disease Research Laboratory test (VDRL) or RPR positive

Contacts and Locations

Study Contact

Yun Jung Choi, PM

CONTACT

82 10 9199 0164

yunjungchoi@anterogen.com

Jessi Choi, PM

CONTACT

82 10 9199 0164

Principal Investigator

Yun Jung Choi, PM

STUDY_DIRECTOR

Anterogen Co., Ltd.

Study Locations (Sites)

University of Southern California

Los Angeles, California, 90033

United States

Collaborators and Investigators

Sponsor: Anterogen Co., Ltd.

Yun Jung Choi, PM, STUDY_DIRECTOR, Anterogen Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-08

Study Completion Date2025-06

Study Record Updates

Study Start Date2020-09-08

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Foot Ulcer