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Clinical Trial Details

Trial ID: L5740
Source ID: NCT01472432
Associated Drug: Placebo
Title: DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01472432/results
Conditions: Chronic Foot Ulcers
Interventions: DRUG: Placebo|DRUG: vildagliptin
Outcome Measures: Primary: Full Epithelialization of the Wound, Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome. Optic microscopy is used to evaluate the epithelialization of the wound., 3 months of treatment with vildagliptin|Capillary Density, Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome. Capillary density is measured using immunohistochemistry, 3 months of treatment with vildagliptin | Secondary: HIF-1α, The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate HIF-1α concentration. Higher values represent more factor., 3 months|VEGF, The factor is assessed by immunoblot analysis (commercial kits).Arbitrary unit of measure are used to evaluate VEGF concentration. Higher values represent more factor., 3 months|VEGF-R1 (Total and Phosphorylated Form), VEGF-R2 (Total and Phosphorylated Form), The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate VEGF-R1 concentration. Higher values represent more factor., 3 months|iNOS, The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate iNOS concentration. Higher values represent more factor., 3 months
Sponsor/Collaborators: Sponsor: University of Campania Luigi Vanvitelli
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 106
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-05
Completion Date: 2016-01
Results First Posted: 2015-06-04
Last Update Posted: 2016-10-11
Locations: Second university of Naples, Naples, I-80100, Italy
URL: https://clinicaltrials.gov/show/NCT01472432