Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot (stimTcPO2)

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Diagnostic test: Stimulation TcPO2 test

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 Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 14021
    • IKEM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with diabetic foot treated in out-patient foot clinic predominantly for diabetic foot ulcers

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in TcPO2	How change special parameters evaluated during Stimulation TcPO2 test	30 minutes
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute for Clinical and Experimental Medicine
• Collaborators: Motol University Hospital; General University Hospital in Prague

Publications and helpful links

General Publications

• Fejfarova V, Matuska J, Jude E, Pithova P, Flekac M, Roztocil K, Woskova V, Dubsky M, Jirkovska A, Bem R, Husakova J, Lanska V. Stimulation TcPO2 Testing Improves Diagnosis of Peripheral Arterial Disease in Patients With Diabetic Foot. Front Endocrinol (Lausanne). 2021 Dec 10;12:744195. doi: 10.3389/fendo.2021.744195. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: diabetic foot; peripheral arterial disease; TcPO2
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Atherosclerosis; Foot Ulcer; Diabetic Foot; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: TcPO2SDN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No