Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers

Phase 4

• Conditions: Diabetic Foot Ulcer
• Interventions: Drug: placebo; Drug: saxagliptin

• Registration Number: NCT02742233
• Lead Sponsor: Long Min,MD

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Status Verified: 2017-01
• Last Update Submitted: 2017-08-06
• Last Update Posted: 2017-08-08
• Primary Completion: 2017-10
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of participants with complete healing during the treatment period.	16 weeks	Complete ulcer closure is defined as 100% skin re-epithelialization

Trial Locations

Locations (1)

The Second Affiliated Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China