Recruiting
Early Phase 1

Nutrition

Sponsor:

Boston Medical Center

Code:

NCT03529019

Conditions

Critical Limb Ischemia

Malnutrition

Nutritional Supplements

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ensure Surgery Immunonutrition Shake

Ensure Enlive Advanced Nutrition Shake

Study Details

Brief 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

Study ID

NCT03529019

Start date

Oct 2, 2018

Status verified date

Jun, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Nutritional Supplement

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

Interventions

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.

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. .

Primary outcome measure

  • Change in serum albumin levels [ Time Frame: baseline and 30 days ]
  • Change in prealbumin levels [ Time Frame: baseline and 30 days ]
  • Change in transferrin levels [ Time Frame: baseline and 30 days ]
  • Change in C-reactive protein levels [ Time Frame: baseline and 30 days ]

Central Contacts and Locations

Central contacts

Jeffrey J Siracuse, MD

617-638-8488Jeffrey.Siracuse@bmc.org

Myriam Castagne, B.S

617-638-8622Myriam.Castagne@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Jeffrey J Siracuse, MD

617-638-8488Jeffrey.Siracuse@bmc.org

Myriam Castagne, BS

617-638-8622mycastag@bu.edu

More Information

Sponsor

Boston Medical Center

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Enhanced Recovery After Surgery Protocol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-06-30.