A Controlled Clinical Trial of Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Completely healing time of the participants'target ulcer during the treatment period.
Study Overview
Brief Summary
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
Groups:
Diabetic ulcers, saxagliptin + Regular treatment.
Diabetic ulcers, placebo + Regular treatment.
Time Point:
Initial treatment;
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
saxagliptin
saxagliptin & Regular treatment:
saxagliptin, brand name，Bristol-Myers, Squibb, dose: 5mg, po, qd
Intervention: saxagliptin (Drug)
placebo
placebo & Regular treatment:
placebo, dose: 5mg, po, qd
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Completely healing time of the participants'target ulcer during the treatment period.
Time Frame: 16 weeks
Complete ulcer closure is defined as 100% skin re-epithelialization
Secondary Outcomes
- Proportion of participants with complete healing during the treatment period.(16 weeks)
Investigators
Long Min,MD
Principal Investigator
Xinqiao Hospital of Chongqing