Peripheral Arterial Disease Clinical Trial
Official title:
Stimulation Testing Performed During TcPO2 Measurement Improve the Diagnosis of Peripheral Arterial Disease in Patients With Diabetic Foot: A Multicentre Trial
All diagnostic procedures of peripheral arterial disease (PAD) in the diabetic foot (DF) are limited due to diabetes mellitus and its late complications. The aim of our study is to refine the diagnosis of peripheral arterial disease (PAD) by a new transcutaneous oximetry (TcPO2) stimulation test (a modified Ratschow test) in patients with diabetic foot.
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 (time to the adjustment of TcPO2 to the resting
values).
All TcPO2 parameters detected during TcPO2 stimulation test will be correlated with
parameters of macrocirculation (systolic blood pressures (SBP) on tibial arteries and their
Ankle-Brachial Indexes (ABI), toe pressures (TP) and toe-brachial indexesTBI) and DUS
findings (monophasic/triphasic flow in relevant artery supplying measured angiosome)
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