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RECRUITING Early Phase 1 ClinicalTrials.gov

Nutrition in Patient With Critical Limb Ischemia

Sponsor: Boston Medical Center • ClinicalTrials.gov ID: NCT03529019

Registry updated: 2026-09-29
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Description

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.

Interventions

  • Ensure Surgery Immunonutrition Shake (Drug)
    An FDA approved nutritional supplement. Prepackaged product designed to be administered one week prior to and one week post surgical procedures.
  • Ensure Enlive Advanced Nutrition Shake (Drug)
    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. .

Eligibility criteria

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

Conditions

Critical Limb Ischemia Malnutrition Nutritional Supplements

Locations

  • Boston Medical Center — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record