Peripheral Microvascular Resistance as a Predictor for Limb Salvage

Launched by HACKENSACK MERIDIAN HEALTH · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to predict whether patients with severe leg circulation problems, known as critical limb ischemia, can keep their limbs and avoid amputation. Researchers want to see if measuring blood flow in small blood vessels in the legs can help determine if patients will benefit from certain medical procedures designed to improve blood flow. This concept is similar to a method used in heart patients, where measuring blood flow helps doctors understand heart health.

To be eligible for this study, participants must be at least 18 years old and have chronic critical limb ischemia, which means they have very poor blood flow to their legs. However, people with certain conditions, such as severe infections or other health issues that would make the study unsafe, will not be able to participate. If enrolled, participants will undergo tests to measure their blood flow, and the results will help doctors understand how well their small blood vessels are functioning. It’s important for potential participants to read and understand the consent form, as well as to be willing to follow the study guidelines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Chronic critical limb ischemia (Rutherford 4-6).
• • Age ≥18 years
• • Ability and willingness to sign the IRB approved Informed Consent form
• Exclusion Criteria:
• • Non-reconstructable chronic total occlusive disease of the proximal inflow vessels that would make flow reserve measurements impossible.
• • Non-salvageable lower extremity due to infection or overwhelming per-existing tissue loss (most critical Rutherford 6 patients).
• • Inability to understand the study or a history of non-compliance with medical advice;
• • History of any cognitive or mental health status that would interfere with study participation;
• • Currently enrolled in any pre-approval investigational study.
• • Female subjects who are pregnant or nursing or planning to become pregnant within the study period;
• • Known sensitivity to contrast media, which can't be adequately pre-medicated;
• • Expected life span less than 6 months.
• • Unable to read/understand/sign the English Language consent form