DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes
DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in 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.
Inclusion Criteria:

 -  Type 2 diabetes

 -  Oral hypoglycemic agents treatment

 -  Chronic foot ulcers

 -  Adequate blood circulation (perfusion) was assessed by a dorsum transcutaneous oxygen
 test >30 -mmHg, anklebrachial index values > 0.7 and < 1.2 with toe pressure > 30
 mmHg, or Doppler arterial aveforms that were triphasic or biphasic at the ankle of the
 affected leg

 -  Written consensus

 Exclusion Criteria:

 -  Active Charcot disease

 -  Ulcers resulting from electrical, chemical, or radiation burns

 -  Collagen vascular disease

 -  Ulcer malignancy

 -  Untreated osteomyelitis, or cellulitis

 -  Ulcer treatment with normothermic or hyperbaric oxygen therapy

 -  Concomitant medications such as corticosteroids, immunosuppressive medications, or
 -chemotherapy

 -  Recombinant or autologous growth factor products

 -  Skin and dermal substitutes within 30 days of study start

 -  Use of any enzymatic debridement treatments

 -  Pregnant or nursing mothers