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Delivery of Yamani-15/5 Chemical Solution for PAD

NCT02539303 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-08-04

No results posted yet for this study

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).

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

Yamani-15/5 chemical solution

A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution.

Sponsors & Collaborators

Principal Investigators

  • Houssam Farres, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2022-08-31
Completion
2023-08-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02539303 on ClinicalTrials.gov