Delivery of Yamani-15/5 Chemical Solution for PAD

• Status: Active, not recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Pharmaceutical Solutions

Criteria

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.