A Phase 1 interventional study of Yamani-15/5 chemical solution in Peripheral Arterial Disease, sponsored by Mayo Clinic. Withdrawn. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-08-04.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment
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).
1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.
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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:
Infusion of Yamani-15/5 chemical solution.
Drug: Yamani-15/5 chemical solution
A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution.
Feasibility
Percent of arterial lumen patency measured by angiography and compared to baseline.
Time frame: Change from baseline
Safety as measured by the number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0.
Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0.
Time frame: Compared to baseline
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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