NCT03529019 Nutrition in Patient With Critical Limb Ischemia
| NCT ID | NCT03529019 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Boston Medical Center |
| Condition | Critical Limb Ischemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2018-10-02 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2018-10-02 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Jeffrey J Siracuse, MD
PRINCIPAL INVESTIGATOR
Boston Medical Center
Frequently Asked Questions
Who can join the NCT03529019 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Critical Limb Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03529019 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03529019 currently recruiting?
Yes, NCT03529019 is actively recruiting participants. Contact the research team at Jeffrey.Siracuse@bmc.org for enrollment information.
Where is the NCT03529019 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03529019 clinical trial?
NCT03529019 is sponsored by Boston Medical Center. The principal investigator is Jeffrey J Siracuse, MD at Boston Medical Center. The trial plans to enroll 30 participants.