Mt. Sinai Medical Center, Miami is recruting for its clinical trial of applying chelation therapy with disodium EDTA to diabetic patients with critical limb ischemia and peripheral artery disease.
The purpose of this research study is to evaluate the effect of ethylenediaminetetraacetic acid (EDTA) based chelation therapy plus vitamins in diabetic patients with severe peripheral artery disease presenting with impending amputation and determine if there is an improvement in outcomes and a delay or reduction of amputations.
The investigators propose to enroll 10 patients in an open-label study of TACT-formula, EDTA-based chelation therapy + commercially available TACT oral multi vitamins, delivering 40-50 infusions over 1 year. Clinical assessment, and noninvasive blood flow assessments will be performed at baseline, and at completion of 20 and 40 infusions. HIPAA-compliant photographs of the affected lower limbs will be taken at each infusion visit.
Ages eigible for study is 50 and plus, both female and male.
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Clinical trial identifier for this project is NCT03424746.