Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot

Launched by INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE · May 21, 2020

Keywords

ClinConnect Summary

Patients with diabetic foot and mild to moderate PAD (WIfI - Ischemia 1 or 2) with baseline TcPO2 values 30-50 mmHg will be included into the study. TcPO2 will be measured on the feet in different angiosomes. During this measurement a stimulation test consisting of a modified Ratschow test involving 2 minutes of exercise will be conducted. Specific TcPO2 parameters will be assessed during the whole procedure (resting TcPO2 before stimulation test, minimal TcPO2, delta TcPO2 (minimum TcPo2 minus resting TcPO2) percentage decrease of TcPO2 during the stimulation test and TcPO2 recovery time (...

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Eligibility criteria

• Inclusion Criteria:
• • presence of Diabetic Foot in patients with type 1 or type 2 diabetes mellitus, with WIfI classification of ischemia 1-2 (based on TcPO2) without previously diagnosed PAD or with known PAD based on the patients' history or previous vascular reconstruction (endovascular or surgical vascular interventions)
• • resting TcPO2 values between 30-50 mm Hg.
• Exclusion Criteria:
• • vascular interventions on evaluated limb within 12 months prior to the enrolment into the study
• * factors possibly influencing for example oxygen saturation or feet movement:
• • patient imobility
• • impairment of movements at the talocrural joints
• • vasculitis
• • heart failure or advanced COPD
• • severe anaemia (plasma haemoglobin below 8g / dL)
• • hypoperfusion due to shock or cardiac dysfunction
• • sepsis
• • massive swelling of the lower limbs of various ethiology (including lymphedema)
• • active Charcot osteoarthropathy
• • critical limb ischemia with WIfI classification of ischemia 3
• • lower limb claudication below 200m
• • venous insufficiency of CEAP classification 6
• • severe diabetic kidney disease (CKD stage 4 or 5)