Delivery of Yamani-15/5 Chemical Solution for PAD

In-vivo Demineralization of Calcific Peripheral Arterial Disease (PAD) Using Local Delivery of Yamani-15/5 Chemical Solution

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 Overview

• Status: Withdrawn
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Drug: Yamani-15/5 chemical solution

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Infusion of Yamani-15/5 chemical solution.	Drug: Yamani-15/5 chemical solution; A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Percent of arterial lumen patency measured by angiography and compared to baseline.	Change from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Compared to baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 2, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 15-001279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No