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Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot — stimTcPO2  

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

Clinical Trial Summary

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.

Clinical Trial Description

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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04404699
Study type Observational [Patient Registry]
Source Institute for Clinical and Experimental Medicine
Contact
Status Completed
Phase
Start date January 1, 2018
Completion date April 1, 2020
View Details
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