Delivery of Yamani-15/5 Chemical Solution for PAD

Phase 1

Withdrawn

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Yamani-15/5 chemical solution

• Registration Number: NCT02539303
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-03
• Status Verified: 2022-08
• Primary Completion: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Yamani-15/5 chemical solution	Infusion of Yamani-15/5 chemical solution.

Primary Outcome Measures

Name	Time	Method
Feasibility	Change from baseline	Percent of arterial lumen patency measured by angiography and compared to baseline.

Secondary Outcome Measures

Name	Time	Method
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.