PERIPHERAL ARTERIOPATHY MedDRA version: 14.1 Level: SOC Classification code 10047065 Term: Vascular disorders System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: TRENTAL*IV 5F 100MG 5ML
Pharmaceutical Form: Solution for infusion
CAS Number: 6493-05-6Y
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 100-
Sponsors
UNIVERSITA' CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age> 55 years - Moderate to severe arterial disease stage (Stage IIb and III sec. Fontaine) - walking capacity 50% of restriction of the vessel lumen) at the superficial femoral artery Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Refusal of patients to participate in the study; - Cognitive deterioration (MMSE <24). - IRC severe (creatinine clearance <30 ml / minute) - Arterial leg stage IV sec. Fontaine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the effectiveness of treatment with pentoxifylline;Secondary Objective: whether and how the outcome of treatment with pentoxifylline in the long term is not influenced by hemodynamic variables;Primary end point(s): - Test of the six-minute walk - Percutaneous oximetry (electrodes positioned lower third leg, the middle third of leg and dorsum of the foot limb revascularized) - Angio-MRI lower extremity - Dynamometry segmental level of the quadriceps and gastrocnemius muscle of the limb revascularized;;Timepoint(s) of evaluation of this end point: one month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluation of multidimensional (VMD) (which includes the MMSE, GDS, ADL, IADL) - EPIC questionnaire (questionnaire which aims to investigate the relationships between diet, environmental factors and lifestyle, and incidence of cancer and other chronic diseases). - PASE Questionnaire (questionnaire aims to assess the level of habitual physical activity of the patient) - Percutaneous segmental Oximetry: electrode placed at the lower third of thigh, the middle third of leg and dorsum of the foot to revascularize the limb; - Arterial blood gas analysis; - Segmental Dynamometry: estimating the strength of three different measurements at the level of the quadriceps muscle and gastrocnemius muscle from revascularize the limb;;Timepoint(s) of evaluation of this end point: one month | — |
Countries
Italy
Contacts
Public ContactGERIATRIA
UNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
Outcome results
None listed