Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot

NCT ID: NCT04404699

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-04-01

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)

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

Stimulation TcPO2 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.

Intervention Type: DIAGNOSTIC_TEST

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
• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General University Hospital, Prague

OTHER

Sponsor Role: collaborator

Motol University Hospital

OTHER

Sponsor Role: collaborator

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Vladimíra Fejfarová

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IKEM

Prague, , Czechia

Countries

Czechia

References

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.

Reference Type: DERIVED

PMID: 34956078 (View on PubMed)

Other Identifiers

TcPO2SDN

Identifier Type: -

Identifier Source: org_study_id