Evaluation the effect of aspirin with and without rivaroxaban in lower extremity symptomatic peripheral artery disease in diabetic patient

Phase 3

• Conditions: Type 2 diabetic patients with symptomatic peripheral vascular complications of the lower extremities.; Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene; E11.51

• Registration Number: IRCT20220502054720N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Diabetic type2 patients ( FBS > 126 , 2hpp > 180 , HBA1c > 6.5% )
lower extremity symptomatic peripheral artery disease

Exclusion Criteria

Patients who used Clopidogrel,
revascularization treatment,
joint disorder
hemoglobin A1C over and equal to 7.5%

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Claudication. Timepoint: At the beginning of the study and 1 and 3 months after taking aspirin with and without rivaroxaban. Method of measurement: Claudication= Fanton criterion and question from the patient.;Nocturnal pain. Timepoint: At the beginning of the study and 1 and 3 months after taking aspirin with and without rivaroxaban. Method of measurement: Question from the patient.;Wound healing. Timepoint: At the beginning of the study and 1 and 3 months after taking aspirin with and without rivaroxaban. Method of measurement: Observation of the facilitator.;ABI. Timepoint: At the beginning of the study and 1 and 3 months after taking aspirin with and without rivaroxaban. Method of measurement: Ultrasound.