A Study of the Delivery of Yamani-15/5 Chemical Solution for Peripheral Artery Disease

Overview

About this study

This is a feasibility 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 who were deemed to have unreconstructable arterial disease and who have already been scheduled to undergo below knee or above knee amputation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria

  • Severe calcific peripheral artery disease deemed to be unreconstructable  
  • Scheduled to undergo below knee or above knee amputation

 

Exclusion Criteria

  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Houssam Farres, M.D.

Contact us for the latest status

Contact information:

Mauricia Buchanan R.N.

127or7839455

Buchanan.Mauricia@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20151957

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