Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot

Peripheral Arterial Disease Clinical Trial

— stimTcPO2  

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 Details — Status: Completed

Administrative data

• NCT number: NCT04404699
• Other study ID #: TcPO2SDN
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2020
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 1, 2020
• Est. primary completion date: March 1, 2020
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Foot
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Czechia	IKEM	Prague

Sponsors (3)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine	General University Hospital in Prague, Motol University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in TcPO2	How change special parameters evaluated during Stimulation TcPO2 test	30 minutes
Primary	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	30 minutes
Secondary	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	30 minutes