drugset / Trial / NCT02539303
Delivery of Yamani-15/5 Chemical Solution for PAD
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D-Gluconic acid | Unknown | 5 % | Other |
| Subject | L-Lactic acid | Small molecule | 15 % | Other |