Delivery of Yamani-15/5 Chemical Solution for PAD



Status:Recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:2/21/2019
Start Date:August 2015
End Date:August 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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).


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.
We found this trial at
1
site
Mayo Clinic Florida
4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Phone: 904-953-2000
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