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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| saxagliptin | Experimental | saxagliptin & Regular treatment: saxagliptin, brand name,Bristol-Myers, Squibb, dose: 5mg, po, qd |
|
| placebo | Placebo Comparator | placebo & Regular treatment: placebo, dose: 5mg, po, qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saxagliptin | Drug | Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive saxagliptin with regular treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Completely healing time of the participants'target ulcer during the treatment period. | Complete ulcer closure is defined as 100% skin re-epithelialization | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with complete healing during the treatment period. | Complete ulcer closure is defined as 100% skin re-epithelialization | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Net change from baseline in laboratory test results | Baseline, weeks 1, 2,4, | |
| New ulcers | new ulcers among the participants during treatment period | 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Long, MD | Contact | 023-68763255 | longmin_casper@163.com | |
| Leiqin Cai | Contact | 18580027792 | caileiqin@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongting Zheng, Ph.D | Department of Endocrinology,The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital, Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
age,the grade of the diabetic ulcers, sex, diabetes duration, healing time, treatment. ect
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 25, 2017 | |
| Reset | Sep 20, 2018 | |
| Release | Dec 3, 2018 | |
| Reset | Mar 15, 2019 | |
| Release | Nov 26, 2022 | |
| Reset | Sep 15, 2023 | |
| Release | Sep 18, 2023 | |
| Reset | Mar 22, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 25, 2017 | Sep 20, 2018 | |||
| Dec 3, 2018 |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| C502994 | saxagliptin |
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|
| placebo | Drug | Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive placebo with regular treatment |
|
|
| Mar 15, 2019 |
| Nov 26, 2022 | Sep 15, 2023 |
| Sep 18, 2023 | Mar 22, 2024 |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |