drugset / Trial / NCT02539303

Delivery of Yamani-15/5 Chemical Solution for PAD

NCT02539303 ↗

Phase 1 Withdrawn Mayo Clinic
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2015-08
Primary completion
2022-08
Completion
2023-08

Outcome

Outcome not reported

Stopped (Enrollment): “Unable to enroll subjects”

Drugs

EvaluationDrugModalityDoseRoute
Subject D-Gluconic acid Unknown 5 % Other
Subject L-Lactic acid Small molecule 15 % Other