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Search / Trial NCT06391346

Investigation of the Perfusion of Gluteal Muscle in Patients With Intermittent Gluteal Claudication by Non-invasive MSOT

Launched by ULRICH ROTHER · Apr 28, 2024

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Peripheral Vascular Diseases Peripheral Arterial Disease Peripheral Artery Disease Pad Gluteal Claudication Buttock Claudication Msot Multispectral Optoacoustic Tomography

ClinConnect Summary

This clinical trial is looking at how well blood flows to the gluteal muscles in patients who experience gluteal claudication, which is a type of leg pain that happens during physical activity due to poor blood circulation. The researchers are using a special non-invasive imaging technique called multispectral optoacoustic tomography (MSOT) to better understand blood flow in these patients before and after they receive treatment. The goal is to develop new ways to assess how well the gluteal muscles are being supplied with blood, which can help in diagnosing and managing this condition.

To be eligible for the study, participants must be between the ages of 65 and 74 and have gluteal claudication in a specific stage of the disease. This means they experience pain in the buttocks or thighs when walking but may have better blood flow when resting. People with other stages of peripheral artery disease, those under 18, or with certain health issues may not be able to participate. If someone joins the trial, they can expect to undergo assessments using the MSOT technique, and their progress will be monitored throughout the study. This research could be important for improving treatment options for people with similar conditions in the future.

Gender

ALL

Eligibility 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

About Ulrich Rother

Ulrich Rother is a dedicated clinical trial sponsor with extensive expertise in the development and management of innovative therapeutic solutions. Committed to advancing medical research, Rother focuses on fostering collaboration among diverse stakeholders, including academic institutions, healthcare professionals, and regulatory bodies. By prioritizing patient safety and data integrity, the organization aims to accelerate the delivery of groundbreaking treatments to the market, ultimately improving health outcomes and enhancing quality of life for patients worldwide. With a strong emphasis on ethical practices and scientific rigor, Ulrich Rother plays a pivotal role in the evolution of clinical research.

Locations

Erlangen, Bavaria, Germany

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported