Assessing temperature changes in legs before and after vascular procedures
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
University Hospitals Cleveland Medical Center · NCT06544135
This study is testing if measuring leg temperatures with a thermal camera before and after surgery can help predict how well patients with peripheral arterial disease will do after their procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center (other) |
| Locations | 3 sites (Beachwood, Ohio and 2 other locations) |
| Trial ID | NCT06544135 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of using a thermal imaging camera to measure temperature changes in the lower extremities of patients with peripheral arterial disease undergoing revascularization procedures. Patients will have their leg temperatures measured before and after the intervention to determine if these measurements can predict the outcomes of the procedures. Data will be collected at multiple time points, including pre-intervention and weekly follow-ups for up to six months. The study will also document relevant comorbidities and demographic factors to correlate with the thermal imaging results.
Who should consider this trial
Good fit: Ideal candidates are patients with lower extremity peripheral artery disease and tissue loss who are scheduled for endovascular intervention.
Not a fit: Patients with non-arterial ulcers or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to predict the outcomes of vascular interventions, potentially improving patient management.
How similar studies have performed: While the use of thermal imaging in vascular assessments is emerging, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI. * Planned lower extremity endovascular intervention Exclusion Criteria: * Non-arterial ulcers * Pregnant
Where this trial is running
Beachwood, Ohio and 2 other locations
- University Hospitals Ahuja Medical Center — Beachwood, Ohio, United States (RECRUITING)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
- University Hospitals Parma Medical Center — Parma, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Jun Li, MD — University Hospitals
- Study coordinator: Jun Li, MD
- Email: jun.li@uhhospitals.org
- Phone: (734) 968-5212
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.
Conditions: Peripheral Arterial Disease, Critical Limb Ischemia, Critical Lower Limb Ischemia