Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

Wolfgang-Michael Franz

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Diabetic Foot

Interventions

SitagliptinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

mean ulcer size after a treatment period of 12 weeks

Time frame: 12 weeks

Data from ClinicalTrials.gov

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