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Completed

NCT Number: NCT04404699

Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Peripheral Vascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IKEM

Prague, 14021, Czechia

About this study

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)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Stimulation TcPO2 test

Diagnostic 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.

Primary outcomes

  1. Changes in TcPO2

    Time frame: 30 minutes

    How change special parameters evaluated during Stimulation TcPO2 test

  2. 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

Secondary outcomes

  1. Correlation of stimulation TcPO2 parameters with macrocirculation parameters

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Collaborators

  • General University Hospital, Prague
  • Motol University Hospital

Registry information

Official study title

Stimulation Testing Performed During TcPO2 Measurement Improve the Diagnosis of Peripheral Arterial Disease in Patients With Diabetic Foot: A Multicentre Trial

Acronym: stimTcPO2

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 27, 2020
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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