An exploratory, open label, single arm study to assess the effect of Patch ItÂ® on blood circulation. - Circupatch

Vedic Lifesciences Pvt Ltd0 个研究点目标入组 12 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients capable of giving informed consent to participate in the study of their own free will.
•Ankle-brachial index of <1.0 but >= 0.50 at rest in at least one leg
•Arterial doppler of common femoral artery - Biphasic waveform, peak systolic velocities (PSV) distal/PSV proximal ratio < 2:1 and less than 50% stenosis

•Patients with clinical evidence of varicose veins and with history or a pre-disposition for deep vein thrombosis
•Patients with absent arterial pulsations in the lower limb
•Patients with ulcerative lesions on the foot that would interfere with the application of the patch
•Patients with history of severe claudication
•Ankle brachial index < 0.5 which is suggestive of severe arterial occlusive disease.
•Any cardiac, hepatic, renal, hemopoietic disease, endocrinal or other systemic disease which in the opinion of the Investigator is not suitable for the study
•Patients using vasodilators, diuretics, low sodium salt and/or potassium salt as determined by history or previous reports of the patient
•Female patients who are pregnant, or lactating, or who plan to become pregnant
•Known hypersensitivity or allergy to one or more of the ingredients of the Investigational Product ( IP)
•Patients otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the study
•Patients with clinically significant abnormal laboratory readings done at the screening visit like Complete blood count (CBC), Erythrocyte sedimentation rate (ESR), Serum glutamic pyruvic transaminase (SGPT), Serum Creatinine (Sr. Creatinine), Urine Routine(UR)

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