Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT04404699
• Lead Sponsor: Institute for Clinical and Experimental Medicine

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)

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-04-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-21
• Last Update Submitted: 2020-05-21
• Study First Posted: 2020-05-27
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of stimulation TcPO2 parameters with the type of peripheral arterial flow	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	30 minutes	How change special parameters evaluated during Stimulation TcPO2 test

Secondary Outcome Measures

Name	Time	Method
Correlation of stimulation TcPO2 parameters with macrocirculation parameters	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

Trial Locations

Locations (1)

IKEM; 🇨🇿 Prague, Czechia