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RECRUITING Early Phase 1

Nutrition in Patient With Critical Limb Ischemia

NCT03529019 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Ensure Surgery Immunonutrition Shake
  • DRUG Ensure Enlive Advanced Nutrition Shake

Study Locations (1)

Massachusetts

  • Boston Medical Center — Boston

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2018-10-02
Est. Completion 2026-06
Phase Early Phase 1

Sponsor

Boston Medical Center

192 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03529019

The ClinicalTrials.gov registry entry for NCT03529019 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 192 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Critical Limb Ischemia appearing as the primary indexed condition, and to 2 interventions — of which Ensure Surgery Immunonutrition Shake is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03529019 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03529019 about?

NCT03529019 is a clinical study titled "Nutrition in Patient With Critical Limb Ischemia". 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 functi...

What is the current status of trial NCT03529019?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2018-10-02. Estimated completion is 2026-06.

What conditions does trial NCT03529019 study?

This clinical trial studies the following conditions: Critical Limb Ischemia, Malnutrition, Nutritional Supplements. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03529019?

The interventions under investigation include: Ensure Surgery Immunonutrition Shake (DRUG), Ensure Enlive Advanced Nutrition Shake (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03529019?

This trial is sponsored by Boston Medical Center, which has 192 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03529019 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial