Nutritional support for patients with Critical Limb Ischemia
Perioperative Nutritional Optimization in Patients With Critical Limb Ischemia
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 |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03529019 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Critical Limb Ischemia.
Not a fit: Patients who are pregnant, lactating, or have advanced chronic kidney disease may not benefit from this study.
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 performed: While there is limited research specifically on vascular surgery patients, other studies have shown that nutritional optimization can improve outcomes in general surgical populations.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.