Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

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

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-03-31

Brief Summary

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The purpose of the study is to test the effect of Sitagliptin on the healing of stable, nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial.

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Detailed Description

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Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sitagliptin

Sitagliptin tablets, 100mg per day, 12 weeks treatment

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

Placebo

Placebo tablets, 1 tablet per day, 12 weeks treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Sitagliptin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Chemical Abstracts Service (CAS) number 654671-77-9

Eligibility Criteria

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Inclusion Criteria

* type 2 diabetes mellitus
* at least 1 diabetic foot ulcer with a size between 1 and 20 sqcm
* stable size of the foot ulcer for at least 2 weeks
* HbA1c \<= 8% under Treatment with Insulin, metformin, sulfonylureas, SGLT2 Inhibitors, glinides or glitazones

Exclusion Criteria

* local purulent signs of Inflammation at ulcer site
* planned interventional or surgical therapy of a macro vessel disease of the lower limb
* glomerular filtration rate \<30ml/min
* liver cirrhosis CHILD B or C
* pregnancy, lactation
* allergy against Sitagliptin
* ongoing treatment with dipeptidyl peptidase 4 (DPP4) Inhibitors

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No