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Nutrition in Patient With Critical Limb Ischemia

NCT03529019 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-31

No results posted yet for this study

Summary

A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from nutritional intervention. The investigators plan to evaluate nutrition and functional status of patients by assessing objective lab values and the use of the hand grip strength test. Providing perioperative nutritional supplements to patients has potentially improved their nutritional status, which in turn may improve the patient's clinical status after surgery.

Conditions

  • Critical Limb Ischemia
  • Malnutrition
  • Nutritional Supplements

Interventions

DRUG

Ensure Surgery Immunonutrition Shake

An FDA approved nutritional supplement. Prepackaged product designed to be administered one week prior to and one week post surgical procedures.

DRUG

Ensure Enlive Advanced Nutrition Shake

An FDA approved nutritional supplement. Prepackaged product designed to be administered 2 weeks prior to and 2 weeks post surgical procedure for a period of one week. .

Sponsors & Collaborators

  • Vascular & Endovascular Surgery Society

    collaborator UNKNOWN

  • Abbott

    collaborator INDUSTRY

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey J Siracuse, MD · Boston Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03529019 on ClinicalTrials.gov