Stimulation Testing Performed During TcPO2 Measurement Improve the Diagnosis of Peripheral Arterial Disease in Patients With Diabetic Foot: A Multicentre Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Institute for Clinical and Experimental Medicine
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Correlation of stimulation TcPO2 parameters with the type of peripheral arterial flow
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed 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)
Investigators
Vladimíra Fejfarová
Principal investigator
Institute for Clinical and Experimental Medicine
Eligibility Criteria
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
- •massive swelling of the lower limbs of various ethiology (including lymphedema)
- •active Charcot osteoarthropathy
Outcomes
Primary Outcomes
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
Changes in TcPO2
Time Frame: 30 minutes
How change special parameters evaluated during Stimulation TcPO2 test
Secondary Outcomes
- Correlation of stimulation TcPO2 parameters with macrocirculation parameters(30 minutes)