This trial is active, not recruiting.

Condition chronic foot ulcers
Treatments placebo, vildagliptin
Phase phase 4
Sponsor Second University of Naples
Start date May 2011
End date December 2011
Trial size 106 participants
Trial identifier NCT01472432, IT 345461


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Placebo Comparator)
In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.
Placebo is added to the standard good medical practice.
The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.

Primary Outcomes

Full epithelialization of the wound
time frame: 4 months of treatment with vildagliptin
Capillary density
time frame: 4 months of treatment with vildagliptin

Secondary Outcomes

time frame: 4 months
time frame: 4 months
VEGF-R1 (total and phosphorylated form)
time frame: 4 months
VEGF-R2 (total and phosphorylated form)
time frame: 4 months
time frame: 4 months

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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

Additional Information

Official title Dipeptidyl Peptidase (DPP) IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Patients With Type 2 Diabetes
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Second University of Naples.