Delivery of Yamani-15/5 Chemical Solution for PAD

Mayo Clinic

Status and phase: Withdrawn; Phase 1

Conditions: Peripheral Arterial Disease

Treatments: Drug: Yamani-15/5 chemical solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02539303

15-001279

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Intervention

Experimental group

Description:

Infusion of Yamani-15/5 chemical solution.

Treatment:

Drug: Yamani-15/5 chemical solution