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Nutritional Supplements for Critical Limb Ischemia (NutriVasc Trial)

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
Must not have
Patients who are on dialysis
Female patients who are pregnant or lactating
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 30 days
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently receiving dialysis.
Select...
I am currently pregnant or breastfeeding.
Select...
My kidney function is severely reduced.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in C-reactive protein levels
Prealbumin
Body Weight Changes
+1 more
Secondary study objectives
Change in Hand grip strength
Other study objectives
Change in ERAS (Enhanced Recovery After Surgery) Malnutrition Screening Test (MST) Scores

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nutritional SupplementExperimental Treatment2 Interventions
Administration of Ensure Surgery Immunonutrition Shake and ensure Enlive Advanced Nutrition Shake.

Find a Location

Who is running the clinical trial?

AbbottIndustry Sponsor
755 Previous Clinical Trials
484,805 Total Patients Enrolled
Boston Medical CenterLead Sponsor
405 Previous Clinical Trials
884,931 Total Patients Enrolled
Vascular & Endovascular Surgery SocietyUNKNOWN
Jeffrey J Siracuse, MDPrincipal InvestigatorBoston Medical Center
1 Previous Clinical Trials
50 Total Patients Enrolled
~2 spots leftby Jun 2025
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