Delivery of Yamani-15/5 Chemical Solution for PAD

Mayo Clinic

Overview

This is a feasibility pilot study to evaluate the impact of local delivery of Yamani-15/5 (combination of L-Lactic acid 15% and D-Gluconic acid 5%) on vascular calcification of lower extremities in patients with severe peripheral arterial disease (PAD) who were deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Peripheral Arterial Disease

Interventions

Yamani-15/5 chemical solutionDRUG

A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Subject has severe calcific PAD who have been deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation). Exclusion: * Patients who will be undergoing amputation of the limb because of infection, osteomyelitis or cancer. * Patients with chronic kidney disease stage V (unless on dialysis). * Patients with liver cirrhosis. * Patients with history of deep vein thrombosis or pulmonary embolization in the last 3 months. * Patients with history of stroke in the last 3 months. * Patients with unstable angina or history of myocardial infarction in the last 3 months. * Patients with sepsis, respiratory failure, hypovolemic shock or cardiogenic shock. * Women who are pregnant or nursing.

Outcomes

Primary Outcomes

Feasibility

Percent of arterial lumen patency measured by angiography and compared to baseline.

Time frame: Change from baseline

Secondary Outcomes

Safety as measured by the number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0.

Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0.

Time frame: Compared to baseline

Data from ClinicalTrials.gov

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