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Nutritional Supplements for Critical Limb Ischemia (NutriVasc Trial)

Q: Who is eligible to join this investigation?

To participate in this trial, volunteers must be afflicted with malnutrition and fit within the 18 to 99 year old demographic. The study is currently seeking 30 qualified individuals.

Q: What is the aggregate figure of participants involved in this experiment?

Indeed, clinicaltrials.gov data suggests that this medical experiment is still recruiting participants. It was first posted on the 2nd of October 2018 and has been recently updated on April 27th 2022. 30 individuals are needed to be recruited from 1 facility for the trial's success.

Q: Are recruitment efforts underway for this research endeavor?

Affirmative, clinicaltrials.gov data indicates that this experiment is recruiting candidates as of now. The trial was first listed on October 2nd 2018 and has been recently updated on April 27th 2022; it requires 30 patients from one medical site for participation.

Q: Are participants of this trial limited to individuals under 45 years old?

The age range for applicable participants of this clinical trial is 18 to 99. There are a total 86 trials that are limited to people under the age of majority, while 456 studies only accept those who have surpassed senior citizenship.

Phase < 1

Recruiting

Led By Jeffrey J Siracuse, MD

Research Sponsored by Boston Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Critical Limb Ischemia

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 30 days

Awards & highlights

NutriVasc Trial Summary

This trial is testing whether nutritional supplements can improve the clinical status of vascular surgery patients with Critical Limb Ischemia.

Who is the study for?

This trial is for patients with Critical Limb Ischemia (CLI), a severe obstruction of the arteries which drastically reduces blood flow to the extremities, leading to malnutrition. It's not open to pregnant or breastfeeding women, nor those with advanced chronic kidney disease or on dialysis.Check my eligibility

What is being tested?

The study is testing two nutritional shakes: Ensure Surgery Immunonutrition Shake and Ensure Enlive Advanced Nutrition Shake. The goal is to see if these supplements can improve nutrition and physical function in CLI patients before and after vascular surgery.See study design

What are the potential side effects?

While specific side effects are not listed, nutritional shakes like Ensure may cause digestive discomfort such as gas, bloating, or diarrhea in some individuals.

NutriVasc Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe blockage in my leg arteries causing pain and sores.

NutriVasc Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in C-reactive protein levels

Prealbumin

Body Weight Changes

+1 more

Secondary outcome measures

Change in Hand grip strength

Other outcome measures

Change in ERAS (Enhanced Recovery After Surgery) Malnutrition Screening Test (MST) Scores

NutriVasc Trial Design

1Treatment groups

Experimental Treatment

Group I: Nutritional SupplementExperimental Treatment2 Interventions

Administration of Ensure Surgery Immunonutrition Shake and ensure Enlive Advanced Nutrition Shake.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbottIndustry Sponsor

751 Previous Clinical Trials

478,145 Total Patients Enrolled

Boston Medical CenterLead Sponsor

384 Previous Clinical Trials

871,600 Total Patients Enrolled

Vascular & Endovascular Surgery SocietyUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to join this investigation?

"To participate in this trial, volunteers must be afflicted with malnutrition and fit within the 18 to 99 year old demographic. The study is currently seeking 30 qualified individuals."

Answered by AI

What is the aggregate figure of participants involved in this experiment?

"Indeed, clinicaltrials.gov data suggests that this medical experiment is still recruiting participants. It was first posted on the 2nd of October 2018 and has been recently updated on April 27th 2022. 30 individuals are needed to be recruited from 1 facility for the trial's success."

Answered by AI

Are recruitment efforts underway for this research endeavor?

"Affirmative, clinicaltrials.gov data indicates that this experiment is recruiting candidates as of now. The trial was first listed on October 2nd 2018 and has been recently updated on April 27th 2022; it requires 30 patients from one medical site for participation."

Answered by AI

Are participants of this trial limited to individuals under 45 years old?

"The age range for applicable participants of this clinical trial is 18 to 99. There are a total 86 trials that are limited to people under the age of majority, while 456 studies only accept those who have surpassed senior citizenship."

Answered by AI

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