Assessing Gluteal Muscle Blood Flow in Patients with Intermittent Claudication
Evaluation of Gluteal Muscle Perfusion in Patients With Intermittent Gluteal Claudication by Non-invasive Multispectral Optoacoustic Tomography With Pre-post Study Design
This study is testing how blood flow in the gluteal muscles changes during exercise in people with intermittent claudication to see if it can help improve diagnosis and treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Erlangen Academic / other |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT06391346 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the blood flow in the gluteal muscles of patients experiencing intermittent claudication due to peripheral arterial disease using multispectral optoacoustic tomography (MSOT). Participants will undergo a stepper exercise to induce claudication pain, after which MSOT measurements will be taken to assess changes in muscle perfusion. The study will also correlate MSOT data with other clinical assessments, including walking distance and quality of life metrics. The goal is to establish independent parameters for diagnosing gluteal muscle perfusion issues pre and post-revascularization.
Who should consider this trial
Good fit: Ideal candidates are patients with gluteal claudication in Fontaine stage II and corresponding stenosis in relevant arteries.
Not a fit: Patients with more severe or less severe stages of peripheral arterial disease, or those with other significant health issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for assessing gluteal claudication and better treatment strategies for patients with peripheral vascular diseases.
How similar studies have performed: While there have been studies on peripheral arterial disease, the specific use of MSOT for assessing gluteal muscle perfusion in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Patient with gluteal claudication in Fontaine stage II and corresponding stenosis (common iliac artery, internal iliac artery or distal aorta) Exclusion Criteria: * Patients with PAD in Fontaine stage I, III and IV or Rutherford category 0, 4, 5 and 6 or healthy volunteers with diabetes mellitus, chronic renal failure, claudication symptoms, abnormal ABI or non-palpable foot pulses * People with age under 18 * Absence of written consent * Safety concerns of the study physician (person with physical, mental or psychiatric conditions which, by the judgement of the study physician, would compromise the person's safety or the quality of the data, thereby rendering the person an ineligible candidate for the study
Where this trial is running
Erlangen, Bavaria
- University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery — Erlangen, Bavaria, Germany (Recruiting)
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.