Delivery of Yamani-15/5 Chemical Solution for PAD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2023-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Infusion of Yamani-15/5 chemical solution.

Group Type EXPERIMENTAL

Yamani-15/5 chemical solution

Intervention Type DRUG

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

Interventions

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Yamani-15/5 chemical solution

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

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No