Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers

Diabetic Foot Ulcer Clinical Trial

— DPP4i  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02742233
• Other study ID #: XinqiaoH
• Status: Recruiting
• Phase: Phase 4
• First received: March 24, 2016
• Last updated: August 6, 2017
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: January 2017
• Source: Xinqiao Hospital of Chongqing
• Contact: Min Long, MD
• Phone: 023-68763255
• Email: longmin_casper[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• saxagliptin
Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive saxagliptin with regular treatment
• placebo
Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive placebo with regular treatment

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Long Min,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Net change from baseline in laboratory test results		Baseline, weeks 1, 2,4,
Other	New ulcers	new ulcers among the participants during treatment period	16 weeks
Primary	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	Proportion of participants with complete healing during the treatment period.	Complete ulcer closure is defined as 100% skin re-epithelialization	16 weeks