Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers (DPP4i)

Long Min,MD

Status and phase: Unknown; Phase 4

Conditions: Diabetic Foot Ulcer

Treatments: Drug: placebo; Drug: saxagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02742233

XinqiaoH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

saxagliptin

Experimental group

Description:

saxagliptin \& Regular treatment: saxagliptin, brand name，Bristol-Myers, Squibb, dose: 5mg, po, qd

Treatment:

Drug: saxagliptin

placebo

Placebo Comparator group

Description:

placebo \& Regular treatment: placebo, dose: 5mg, po, qd

Treatment:

Drug: placebo