Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers

NCT ID: NCT02742233

Last Updated: 2017-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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saxagliptin

saxagliptin \& Regular treatment:

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

Group Type EXPERIMENTAL

saxagliptin

Intervention Type DRUG

Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i.

Treatment Period: Participants will receive saxagliptin with regular treatment

placebo

placebo \& Regular treatment:

placebo, dose: 5mg, po, qd

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i.

Treatment Period: Participants will receive placebo with regular treatment

Interventions

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saxagliptin

Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i.

Treatment Period: Participants will receive saxagliptin with regular treatment

Intervention Type DRUG

placebo

Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i.

Treatment Period: Participants will receive placebo with regular treatment

Intervention Type DRUG

Other Intervention Names

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ONGLYZA dummy pills

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Long Min,MD

OTHER

Sponsor Role lead

Responsible Party

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Long Min,MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hongting Zheng, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology,The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China.

Locations

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The Second Affiliated Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Long, MD

Role: CONTACT

023-68763255

Leiqin Cai

Role: CONTACT

18580027792

Other Identifiers

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XinqiaoH

Identifier Type: -

Identifier Source: org_study_id

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