An interventional study of Near-infrared spectroscopy (NIRS, Medtronic, INVOS) tissue oxygenation monitoring in Chronic Limb Threatening Ischemia and CLTI, sponsored by Belarusian State Medical University. Recruiting at 1 site in Belarus. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Belarusian State Medical University · Not applicable, Interventional, and Diagnostic
Lower-extremity arterial disease in the stage of chronic limb-threatening ischemia (CLTI) carries a high risk of major amputation and death. According to international vascular guidelines for the management of patients with CLTI, revascularization should aim to restore blood flow to the arteries of the foot, ensuring the minimum level of perfusion required for tissue repair and regeneration. However, establishing direct blood flow to the foot arteries is often limited in patients with distal arterial occlusion or multilevel arterial disease. Furthermore, simultaneous multilevel revascularization carries an increased operative risk for patients with significant comorbidities. Collectively, these factors complicate the prediction of optimal limb perfusion-both before and after revascularization-and, consequently, the selection of an appropriate treatment strategy.
Traditional diagnostic methods have limitations in assessing the severity of ischemia, particularly in patients presenting with rest pain and/or trophic lesions.
The study (PERIOX) is to be undertaken to evaluate the use of near-infrared spectroscopy (NIRS, Medtronic, INVOS) - a rapid, simple, non-invasive, and painless method that can be applied to any area of the skin and allows for continuous, real-time monitoring of changes in tissue oxygenation - as a tool for assessing limb viability before, during, and after revascularization in patients with lower-extremity arterial disease presenting with CLTI
357 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 72 are open to participants now.
This study's planned enrollment of 120 is above the median of 41 across 240 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Belarusian State Medical University is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with CLTI are to be included and to be undergone direct arterial revascularization. Tissue oxygenation in the distal lower extremity is to be measured using near-infrared spectroscopy (NIRS; INVOS, Medtronic). NIRS tissue oxygenation is the only intervention.
Diagnostic Test: Near-infrared spectroscopy (NIRS, Medtronic, INVOS) tissue oxygenation monitoring
NIRS tissue oxygenation monitoring is the only intervention.
Changing in regional tissue oxygenation in the distal lower limb (rSO2, %) from baseline before, during surgery, and after lower limb arterial revascularization
The measurement and assessment of tissue oxygenation levels in the distal lower extremity using near-infrared spectroscopy (NIRS, Medtronic, INVOS) will be performed preoperatively (24 hours before surgery), continuously during the arterial reconstructive operation (which lasts 2-6 hours), and postoperatively (at 24 hours and 7 days after surgery) in patients with chronic limb threatening ischemia (CLTI)
Time frame: Baseline, during 24 hours after vascular surgery and 7 days post-procedure
30-day limb salvage rate
Percentage of patients who successfully avoided major lower limb amputation after vascular surgery
Time frame: From surgery to 30 days post-procedure
Started Nov 2026 (actual). Primary completion is estimated for Oct 2027, 11 months after the start.
Of 71 interventional studies with no phase under Chronic Limb-Threatening Ischemia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 85. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Chronic Limb-Threatening Ischemia →
Belarusian State Medical University