Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot (stimTcPO2)
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|ClinicalTrials.gov Identifier: NCT04404699|
Recruitment Status : Completed
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease||Diagnostic Test: Stimulation TcPO2 test|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||79 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Stimulation Testing Performed During TcPO2 Measurement Improve the Diagnosis of Peripheral Arterial Disease in Patients With Diabetic Foot: A Multicentre Trial|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||March 1, 2020|
|Actual Study Completion Date :||April 1, 2020|
- Diagnostic Test: Stimulation TcPO2 test
During measurement of TcPO2 in various angiosomes the stimulation test will be performed. We modify the Ratschow test (elevation of the lower limbs, rhythmic flexion and extension in talocrural joints for 2 minutes, then return to horizontal position). TcPO2 is measured continuously. Depending on the type of detected flows by DUS in the evaluated arteries supplying the relevant angiosome, in which TcPO2 values are measured, the patients and their angiosomes will be divided into 2 baseline groups - group M with monophasic flows or arterial obliterations and group T with triphasic flows.
We will compare macrocirculation parameters-systolic pressure on dorsalis pedis artery (DPA), posterior tibial artery (PTA) and their doppler indexes. The resting TcPO2, the minimal TcPO2 found during the stimulation test, their delta (resting TcPO2 - minimal TcPO2) and the percentage decrease in TcPO2 will be compared between the study groups, as well as the duration of TcPO2 recovery.
- Changes in TcPO2 [ Time Frame: 30 minutes ]How change special parameters evaluated during Stimulation TcPO2 test
- Correlation of stimulation TcPO2 parameters with the type of peripheral arterial flow [ Time Frame: 30 minutes ]A correlation of special parameters detected during Stimulation TcPO2 test with the type of arterial flow in large vessels supplying measured angiosome by TcPO2 will be performed
- Correlation of stimulation TcPO2 parameters with macrocirculation parameters [ Time Frame: 30 minutes ]A correlation of special parameters detected during Stimulation TcPO2 test with the large vessels parameters usually used for PAD diagnosis (systolic blood pressures on ADP, PTA and their ABI and toe pressures and their TBI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404699
|Prague, Czechia, 14021|