Peripheral Arterial Disease
Conditions
Brief 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).
Interventions
DRUGYamani-15/5 chemical solution
A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | Change from baseline | Percent of arterial lumen patency measured by angiography and compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety as measured by the number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0. | Compared to baseline | Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0. |
Outcome results
None listed