Chronic Foot Ulcers Clinical Trial
Official title:
Dipeptidyl Peptidase (DPP) IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Patients With Type 2 Diabetes
A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4 months of vildagliptin on healing of chronic ulcers in type 2 diabetes.
The chronic foot ulcer is a leading cause of hospital admissions for people with diabetes in
the developed world and is a major morbidity associated with diabetes, often leading to
pain, suffering, and a poor quality of life for patients. Chronic diabetic foot ulcers are
estimated to occur in 15% of all patients with diabetes and precede 84% of all
diabetes-related lower-leg amputations.The pathophysiology of chronic diabetic ulcers is
complex and still incompletely understood, the most important predisposing factors being
diabetic neuropathy and vasculopathy. Both micro and macroangiopathy strongly contribute to
development and delayed healing of diabetic wounds, through an impaired tissue feeding and
response to ischemia. HIF-1α and VEGF, as well as the NO production from iNOS, may
contribute to limitation of hypoxic injury by promoting angiogenesis and wound healing.
Experimental and pathological studies suggest that suggest that he incretin hormone
glucagon-like peptide-1 (GLP-1) may improves VEGF generation, and promote pancreatic islet
viability through the up-regulation of HIF1α.
Therefore, aim of this study is to evaluate the effect of the augmentation of GLP-1, by
inhibitors of the dipeptidyl peptidase IV (DPP-4), such as vildagliptin, on HIF-1α, VEGF and
iNOS in diabetic chronic ulcers.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment