Nutritional support for patients with Critical Limb Ischemia
Official title: Perioperative Nutritional Optimization in Patients With Critical Limb Ischemia
Run by Boston Medical Center · NCT03529019 · Data updated 2026-11-12
This study tests if giving nutritional supplements to patients with Critical Limb Ischemia before and after surgery can help them recover better and feel stronger.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | October 2, 2018 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT03529019 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with Critical Limb Ischemia.
✕Probably not a fit
Patients who are pregnant, lactating, or have advanced chronic kidney disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study investigates the effects of nutritional supplements on vascular surgery patients suffering from Critical Limb Ischemia (CLI), a condition often associated with malnutrition. The research aims to evaluate the nutritional and functional status of these patients through objective lab assessments and hand grip strength tests. By providing perioperative nutritional supplements, the study seeks to enhance the patients' nutritional status, potentially leading to improved clinical outcomes following surgery. The study is part of the Enhanced Recovery After Surgery protocol, which emphasizes the importance of nutrition in surgical recovery.
Why it matters
Potential benefit: If successful, this study could significantly improve recovery and health outcomes for patients with Critical Limb Ischemia.
How similar studies have gone: While there is limited research specifically on vascular surgery patients, other studies have shown that nutritional optimization can improve outcomes in general surgical populations.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Boston Medical Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Jeffrey J Siracuse, MD — Boston Medical Center
- Study coordinator: Jeffrey J Siracuse, MD
- Email: Jeffrey.Siracuse@bmc.org
- Phone: 617-638-8488
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.