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Can a simple shake boost recovery from leg artery surgery?

NCT ID NCT03529019

Disease control Sponsor: Boston Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This pilot study tests whether giving special nutritional shakes before and after surgery can improve the health of patients with critical limb ischemia, a severe form of peripheral artery disease. About 30 participants will drink the shakes for one to two weeks before and after their procedure. Researchers will measure blood markers of nutrition and hand grip strength to see if the supplements help.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nutritional supplement shakes (Ensure Surgery Immunonutrition Shake and Ensure Enlive Advanced Nutrition Shake)
What this could lead to
If it works, this could show that simple nutritional supplements improve recovery and reduce complications after surgery for critical limb ischemia.
What could go wrong
This is a very early pilot study with only 30 participants, so results may not apply to everyone. It focuses on lab markers and grip strength, not on major clinical outcomes like limb salvage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2018

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Critical Limb Ischemia Exclusion Criteria: * Female patients who are pregnant or lactating * Chronic Kidney Disease Stages 4 and 5 * Patients who are on dialysis

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia Malnutrition nutritional deficiency disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical limb ischemia Malnutrition Nutritional supplements

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

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