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NCT03529019 · ClinicalTrials.gov registry record · Early Phase 1
Nutrition in Patient With Critical Limb Ischemia
A Early Phase 1 study of Critical Limb Ischemia and Malnutrition, sponsored by Boston Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03529019: Recruiting Early Phase 1 study of Critical Limb Ischemia and Malnutrition, sponsored by Boston Medical Center.
NCT03529019 is a Early Phase 1 study of Critical Limb Ischemia and Malnutrition that is actively recruiting participants, run by Boston Medical Center. The registered enrollment target is 30 participants, below the 90-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03529019, a Early Phase 1 study of Critical Limb Ischemia and Malnutrition, is actively recruiting participants, sponsored by Boston Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Albumin is a carbohydrate-free protein, which constitutes 55% to 65% of total plasma protein. Albumin results can reflect the nutritional status of the body and other problems with the kidney or liver. A normal albumin range is 3.4 to 5.4 g/dL. Albumin levels will be tested on blood samples on each participant obtained at baseline and 30 days after nutritional supplementation. Lower albumin levels are associated with malnutrition
Conditions Studied
Interventions
- DRUG Ensure Surgery Immunonutrition Shake
- DRUG Ensure Enlive Advanced Nutrition Shake
Study Locations (1)
Massachusetts
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-10-02 |
| Est. Completion | 2026-06 |
| Phase | Early Phase 1 |
What NCT03529019 shows while recruiting
NCT03529019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 90-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (67% lower).
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.
NCT03529019 reports a single indexed study location in Massachusetts.
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.
What interventions are being tested in trial NCT03529019?
The interventions under investigation include: Ensure Surgery Immunonutrition Shake (DRUG), Ensure Enlive Advanced Nutrition Shake (DRUG).
Who is sponsoring clinical trial NCT03529019?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03529019's enrollment target sits among peer trials
30 13th of 18 higher than 6 of 18 other Critical Limb Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Limb Ischemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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