Clinical trial NCT04404699: Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot
Official title: Stimulation Testing Performed During TcPO2 Measurement Improve the Diagnosis of Peripheral Arterial Disease in Patients With Diabetic Foot: A Multicentre Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Keywords: diabetic foot
peripheral arterial disease
TcPO2
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
Collaborators: name: General University Hospital, Prague
name: Motol University Hospital
First posted: 2020-05-27
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with diabetic foot treated in out-patient foot clinic predominantly for diabetic foot ulcers

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)

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)

Primary outcomes:
measure: Changes in TcPO2
timeFrame: 30 minutes
measure: Correlation of stimulation TcPO2 parameters with the type of peripheral arterial flow
timeFrame: 30 minutes
Secondary outcomes:
measure: Correlation of stimulation TcPO2 parameters with macrocirculation parameters
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: IKEM
Study officials:
References:
citation: 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.