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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04404699
Recruitment Status : Completed
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborators:
General University Hospital in Prague
Motol University Hospital
Information provided by (Responsible Party):
Vladimíra Fejfarová, 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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease 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)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Stimulation Testing Performed During TcPO2 Measurement Improve the Diagnosis of Peripheral Arterial Disease in Patients With Diabetic Foot: A Multicentre Trial
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404699


Locations
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Czechia
IKEM
Prague, Czechia, 14021
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
General University Hospital in Prague
Motol University Hospital
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Responsible Party: Vladimíra Fejfarová, Principal investigator, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT04404699    
Other Study ID Numbers: TcPO2SDN
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vladimíra Fejfarová, Institute for Clinical and Experimental Medicine:
diabetic foot
peripheral arterial disease
TcPO2
Additional relevant MeSH terms:
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Diabetic Foot
Peripheral Arterial Disease
Peripheral Vascular Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases