Trial | NCT02742233  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    saxagliptin ...

  • Study Participants

    60
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.
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 Started
Nov 30
2015
Primary Completion
Oct 31
2017
Anticipated
Study Completion
Nov 30
2017
Anticipated
Last Update
Aug 08
2017

Drug saxagliptin

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

  • Other names: ONGLYZA

Drug placebo

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

  • Other names: dummy pills

saxagliptin Experimental

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

placebo Placebo Comparator

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

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
No Results Posted