Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Controlled Clinical Trial of Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: saxagliptin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, twice random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl) Ulcer located on the legs or feet, stage III or IV (Wagner Classification System) The subject agrees to comply with study protocol requirements and all follow up visit requirements. Exclusion Criteria: Uncontrolled diabetes Ulcer infection Non-diabetic ulcers Orthopedic or neuromuscular pathologic conditions

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: saxagliptin<br>saxagliptin & Regular treatment: saxagliptin, brand name，Bristol-Myers, Squibb, dose: 5mg, po, qd | Drug: saxagliptin<br>* Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive saxagliptin with regular treatment<br>* Other names: ONGLYZA;|
| Placebo Comparator: placebo<br>placebo & Regular treatment: placebo, dose: 5mg, po, qd | Drug: placebo<br>* Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive placebo with regular treatment<br>* Other names: dummy pills;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Wound Healing, Dipeptidyl Peptidase 4 Inhibition