Diabetic Foot Ulcer
Conditions
Keywords
Diabetes, Wound Healing, Dipeptidyl Peptidase 4 Inhibition
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; Post-treatment ( 1w ); Post-treatment ( 2w ); Post-treatment ( 4w ); Completely healed.
Interventions
DRUGsaxagliptin
Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive saxagliptin with regular treatment
DRUGplacebo
Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive placebo with regular treatment
Sponsors
Long Min,MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completely healing time of the participants'target ulcer during the treatment period. | 16 weeks | Complete ulcer closure is defined as 100% skin re-epithelialization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with complete healing during the treatment period. | 16 weeks | Complete ulcer closure is defined as 100% skin re-epithelialization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Net change from baseline in laboratory test results | Baseline, weeks 1, 2,4, | — |
| New ulcers | 16 weeks | new ulcers among the participants during treatment period |
Countries
China
Contacts
Primary ContactMin Long, MD
Backup ContactLeiqin Cai
Outcome results
None listed