Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot

NCT04404699 | Completed

• 1 other identifier: TcPO2SDN
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

diabetic foot; peripheral arterial disease; TcPO2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Correlation of stimulation TcPO2 parameters with macrocirculation parameters

  30 minutes

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead
• General University Hospital, Prague: collaborator
• Motol University Hospital: collaborator

Study Sites (1)

IKEM

Prague, 14021, Czechia

Location

Related Publications (1)

• 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.

  PMID: 34956078 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 27, 2020
• Study Start: January 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

CZ (1)