Status:
COMPLETED
Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Collaborating Sponsors:
General University Hospital, Prague
Motol University Hospital
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-70 years
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 diagnosi...
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 ang...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04404699
Start Date
January 1 2018
End Date
April 1 2020
Last Update
May 27 2020
Active Locations (1)
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1
IKEM
Prague, Czechia, 14021