Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers

NCT02742233 | Unknown Phase 4 DMC

• 1 other identifier: XinqiaoH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes; Wound Healing; Dipeptidyl Peptidase 4 Inhibition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of participants with complete healing during the treatment period.

  16 weeks

Other Outcomes (2)

• Net change from baseline in laboratory test results

  Baseline, weeks 1, 2,4,

• New ulcers

  16 weeks

Study Arms (2)

saxagliptin

EXPERIMENTAL

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

Drug: saxagliptin

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

saxagliptin DRUG

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

Also known as: ONGLYZA

saxagliptin

placebo DRUG

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

Also known as: dummy pills

placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled diabetes
• Ulcer infection
• Non-diabetic ulcers Orthopedic or neuromuscular pathologic conditions

Sponsors & Collaborators

• Long Min,MD: lead

Study Sites (1)

The Second Affiliated Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hongting Zheng, Ph.D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Long, MD

CONTACT

023-68763255; longmin_casper@163.com

Leiqin Cai

CONTACT

18580027792; caileiqin@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 18, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 8, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)