Nutrition in Patient With Critical Limb Ischemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Medical Center
Study ID
NCT03529019
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Critical Limb Ischemia
  • Malnutrition
  • Nutritional Supplements

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

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. .

Study Details

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.

Key Dates

Start date
Oct 2, 2018
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Nutritional Supplement
    Administration of Ensure Surgery Immunonutrition Shake and ensure Enlive Advanced Nutrition Shake.

Primary Outcome Measure

Change in serum albumin levels [ Time Frame: baseline and 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118
Jeffrey J Siracuse, MD
[email protected]
617-638-8488
Myriam Castagne, BS
[email protected]
617-638-8622

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By research site
Boston Medical Center· Boston, MA

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