A Phase 2 interventional study of ALLO-ASC-SHEET in Diabetic Foot Ulcer, sponsored by Anterogen Co., Ltd.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by Anterogen Co., Ltd. · Phase 2, Interventional, and Treatment
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 64 is close to the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Anterogen Co., Ltd. is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ulcer area blood circulation meets 1 of the following criteria:
A. Blood vessels around the ulcer detected by Doppler Test to have biphasic or triphasic flow B. Range of Ankle Brachial Index(ABI) is>0.7 to \<1.3 C. Transcutaneous oxygen pressure (TcPO2) >30 mmHg.
Exclusion Criteria:
ALLO-ASC-SHEET Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
Biological: ALLO-ASC-SHEET
Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells
Biological: ALLO-ASC-SHEET
Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
Also known as: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
Proportions of subjects who achieved complete wound closure.
Proportions of subjects who achieved complete wound closure during the 12 weeks.
Time frame: During 12 weeks
Time to initial complete wound closure between the 2 groups.
Measure the time to initial complete wound closure between the 2 groups.
Time frame: During 12 weeks
Changes in wound size compared to baseline between the 2 groups.
Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices).
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of wound size.
Proportions of subjects who achieved complete wound closure by the classification of wound size, 1.5\~7 cm2 and 7.1\~15 cm2 between the 2 groups at every visit.
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of location of diabetic foot ulcer.
Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, plantar and dorsal between the 2 groups at every visit by post-hoc analysis.
Time frame: During 12 weeks
Durability of complete wound closure for the additional 24 weeks.
Durability of complete wound closure for the additional 24 weeks from the initial complete wound closure. Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices).
Time frame: During 36 weeks
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Anterogen Co., Ltd.