An observational study in Peripheral Arterial Disease, sponsored by Institute for Clinical and Experimental Medicine. Completed at 1 site in Czechia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by Institute for Clinical and Experimental Medicine · Observational
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)
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 79 is below the median of 100 across 186 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Institute for Clinical and Experimental Medicine is the lead sponsor of 60 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with diabetic foot treated in out-patient foot clinic predominantly for diabetic foot ulcers
Exclusion Criteria:
factors possibly influencing for example oxygen saturation or feet movement:
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
How change special parameters evaluated during Stimulation TcPO2 test
Time frame: 30 minutes
Correlation of stimulation TcPO2 parameters with the type of peripheral arterial flow
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
Time frame: 30 minutes
Correlation of stimulation TcPO2 parameters with macrocirculation parameters
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
Time frame: 30 minutes
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Institute for Clinical and Experimental Medicine