Health Trials

Skin Microcirculation in Patients With Lower Limb Atherosclerosis

ConditionsPercutaneous Transluminal AngioplastyAtherosclerosis of Arteries of the Extremities, Unspecified
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorODI Medical AS

About this trial

The aim of this study is to explore the ability of the non-invasive device ODI-Tech® to monitor changes in microvascular blood flow in patients with lower limb ischemia undergoing the procedure percutaneous transluminal angioplasty (PTA). Microvascular data from patients and healthy case matched controls at baseline will be compared.15 patients and 15 healthy case matched controls will be enrolled.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18

Lower limb atherosclerosis and ischemia in Rutherford grade 3-6

Obstructive infra-inguinal arterial lesions combined with open distal part of the anterior tibial artery

Scheduled for elective PTA

Disqualifiers

Active skin infection at the region of interest (site to be examined, dorsum of hand and foot)

Trial design

Design model

Single group

Treatments tested in this trial

  • Examination with the ODI-Tech medical device

    Device

    Diffuse reflectance spectroscopy and computer-assisted microscopy.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients scheduled for elective PTAOther 1 intervention

Trial outcomes

Primary outcomes

1

Changes in skin microvascular oxygen saturation (SmvO2)

Time frame
From baseline to 40 days post PTA
2

Changes in functional Capillary Density (FCD)

Time frame
From baseline to 40 days post PTA.

Secondary outcomes

1

Incidence of AE/ADE/SAE/SADE/DD

Time frame
From baseline to 40 days post PTA

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ODI Medical AS

Lead sponsor

Source ClinicalTrials.gov
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