Delivery of Yamani-15/5 Chemical Solution for PAD

NCT02539303 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 15-001279
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Percent of arterial lumen patency measured by angiography and compared to baseline.

  Change from baseline

Secondary Outcomes (1)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

Infusion of Yamani-15/5 chemical solution.

Drug: Yamani-15/5 chemical solution

Interventions

Yamani-15/5 chemical solution DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients who will be undergoing amputation of the limb because of infection, osteomyelitis or cancer.
• Patients with chronic kidney disease stage V (unless on dialysis).
• Patients with liver cirrhosis.
• Patients with history of deep vein thrombosis or pulmonary embolization in the last 3 months.
• Patients with history of stroke in the last 3 months.
• Patients with unstable angina or history of myocardial infarction in the last 3 months.
• Patients with sepsis, respiratory failure, hypovolemic shock or cardiogenic shock.
• Women who are pregnant or nursing.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Houssam Farres, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Houssam Farres

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 3, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share