A Phase 4 interventional study of saxagliptin and placebo in Diabetic Foot Ulcer, sponsored by Long Min,MD. Status unknown at 1 site in China. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-08-08.
Sponsored by Long Min,MD · Phase 4, Interventional, and Treatment
To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients with diabetic foot ulcers, the investigators randomly divided the participants into two groups: saxagliptin with regular treatment group，placebo with regular treatment group. The clinical data are collected at the given time point. This study aimed to observe the potential protective effect of DPP4i on diabetic ulcers.
Groups:
Diabetic ulcers, saxagliptin + Regular treatment.
Diabetic ulcers, placebo + Regular treatment.
Time Point:
Initial treatment;
Post-treatment ( 1w );
Post-treatment ( 2w );
Post-treatment ( 4w );
Completely healed.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →This is the only study on the registry with Long Min,MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
saxagliptin \& Regular treatment: saxagliptin, brand name，Bristol-Myers, Squibb, dose: 5mg, po, qd
Drug: saxagliptin
placebo \& Regular treatment: placebo, dose: 5mg, po, qd
Drug: placebo
Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive saxagliptin with regular treatment
Also known as: ONGLYZA
Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive placebo with regular treatment
Also known as: dummy pills
Completely healing time of the participants'target ulcer during the treatment period.
Complete ulcer closure is defined as 100% skin re-epithelialization
Time frame: 16 weeks
Proportion of participants with complete healing during the treatment period.
Complete ulcer closure is defined as 100% skin re-epithelialization
Time frame: 16 weeks
Net change from baseline in laboratory test results
Time frame: Baseline, weeks 1, 2,4,
New ulcers
new ulcers among the participants during treatment period
Time frame: 16 weeks
Plan to share: Yes — age，the grade of the diabetic ulcers, sex, diabetes duration, healing time, treatment. ect
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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