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

Primary Purpose

Diabetic Foot Ulcer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
saxagliptin
placebo
Sponsored by
Long Min,MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetes, Wound Healing, Dipeptidyl Peptidase 4 Inhibition

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Second Affiliated Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

saxagliptin

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Completely healing time of the participants'target ulcer during the treatment period.
Complete ulcer closure is defined as 100% skin re-epithelialization

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2016
Last Updated
August 6, 2017
Sponsor
Long Min,MD
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1. Study Identification

Unique Protocol Identification Number
NCT02742233
Brief Title
Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
Acronym
DPP4i
Official Title
A Controlled Clinical Trial of Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Long Min,MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetes, Wound Healing, Dipeptidyl Peptidase 4 Inhibition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
saxagliptin
Arm Type
Experimental
Arm Description
saxagliptin & Regular treatment: saxagliptin, brand name，Bristol-Myers, Squibb, dose: 5mg, po, qd
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo & Regular treatment: placebo, dose: 5mg, po, qd
Intervention Type
Drug
Intervention Name(s)
saxagliptin
Other Intervention Name(s)
ONGLYZA
Intervention Description
Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive saxagliptin with regular treatment
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
dummy pills
Intervention Description
Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i. Treatment Period: Participants will receive placebo with regular treatment
Primary Outcome Measure Information:
Title
Completely healing time of the participants'target ulcer during the treatment period.
Description
Complete ulcer closure is defined as 100% skin re-epithelialization
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Proportion of participants with complete healing during the treatment period.
Description
Complete ulcer closure is defined as 100% skin re-epithelialization
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Net change from baseline in laboratory test results
Time Frame
Baseline, weeks 1, 2,4,
Title
New ulcers
Description
new ulcers among the participants during treatment period
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Long, MD
Phone
023-68763255
Email
longmin_casper@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leiqin Cai
Phone
18580027792
Email
caileiqin@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongting Zheng, Ph.D
Organizational Affiliation
Department of Endocrinology,The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongting Zheng, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
age，the grade of the diabetic ulcers, sex, diabetes duration, healing time, treatment. ect

Learn more about this trial

Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers

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