CompletedNot Applicable

Contrast Enhanced Ultrasound and Muscle

France32 participantsStarted 2011-02

Plain-language summary

The primary objective of our work is to show that quantification of muscular microvascularisation evaluated by injection of contrast agent is different between chronic critical limb ischemia (before revascularization) and after (healing of ischemia) and thus make the proof of its utility in evaluation of PAD therapeutics.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women over 40 years * Patients with chronic critical limb ischemia as defined by consensus TASC 2 and eligible to a revascularisation * Objective evaluation of critical ischemia is based on ankle pressure \< 70 mm Hg or toe pressure \< 50 mm Hg for patients with ulcer or pressure ankle pressure \< 50 mm Hg or toe pressure \< 30 mm Hg for patients with rest pain. * Patient's consent signed Exclusion Criteria: * Patients under 18 * Pregnant or breast feeding woman * Burger's disease * Contra- indication to use of contrast * Hypersensitivity to sulfurhexafluorure * Unstable coronary heart disease, acute stroke, uncompensated heart failure * Right to left shunt * Serious pulmonary hypertension (\> 90 mm Hg) * Uncontroled increased blood pressure * Acute respiratory distress syndrom * Consent refused * Patients with leg wounds preventing ultrasonography

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to Peak

Timeframe: M0 (before revascularisation) and M1 (One month after the revascularisation).

Trial details

NCT IDNCT02128750

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

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