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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220502054720N1

Enrollment

Registered

2022-10-30

Start date

2021-09-23

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetic patients with symptomatic peripheral vascular complications of the lower extremities. Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene

Interventions

Intervention 1: Intervention group: This group includes 30 patients with type 2 diabetes who have peripheral vascular disease of the lower extremities. Patients in this group will receive aspirin (80

Eligibility

Sex/Gender

All

Age

30 Years to 50 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohaddese Abbasi

Shahid Beheshti University of Medical Sciences

mer3de666@yahoo.com+98 21 8827 0723

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026