Abstract
BackgroundAll diagnostic procedures of peripheral arterial disease (PAD) in diabetic foot (DF) are complicated due to diabetes mellitus and its late complications.The aim of our study is to enhance diagnosis of PAD using a novel transcutaneous oximetry (TcPO2) stimulation test.MethodsThe study comprised patients with mild-to-moderate PAD(WIfI–I 1 or 2) and baseline TcPO2 values of 30-50 mmHg.TcPO2 was measured across 107 different angiosomes. Stimulation examination involved a modification of the Ratschow test. All patients underwent PAD assessment (systolic blood pressures (SBP), toe pressures (TP), the ankle-brachial indexes (ABI) and toe-brachial indexes (TBI), duplex ultrasound of circulation). Angiosomes were divided into two groups based on ultrasound findings: group M(n=60) with monophasic flow; group T(n=47) with triphasic flow. Large vessel parameters and TcPO2 at rest and after exercise (minimal TcPO2, changes in TcPO2 from baseline (Δ,%), TcPO2 recovery time) measured during the stimulation test were compared between study groups.ResultsDuring the TcPO2 stimulation exercise test, group M exhibited significantly lower minimal TcPO2 (26.2 ± 11.1 vs. 31.4 ± 9.4 mmHg; p<0.01), greater Δ and percentage decreases from resting TcPO2 (p=0.014 and p=0.007, respectively) and longer TcPO2 recovery times (446 ± 134 vs. 370 ± 81ms;p=0.0005) compared to group T. SBPs, TPs and indexes were significantly lower in group M compared to group T. Sensitivity and specificity of TcPO2 stimulation parameters during PAD detection increased significantly to the level of SBP, ABI, TP and TBI.ConclusionCompared to resting TcPO2, TcPO2 measured during stimulation improves detection of latent forms of PAD and restenosis/obliterations of previously treated arteries in diabetic foot patients.Clinical Trial RegistrationClinicalTrials.gov [https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009V7W&selectaction=Edit&uid=U0005381&ts=2&cx=3j24u2], identifier NCT04404699
Highlights
All diagnostic procedures of peripheral arterial disease (PAD) in diabetic foot (DF) are complicated due to diabetes mellitus and its late complications.The aim of our study is to enhance diagnosis of PAD using a novel transcutaneous oximetry (TcPO2) stimulation test
A total of 79 patients with DF were enrolled as part of the study (mean age – 66.9 ± 10.2 years; diabetes duration – 19.3 ± 12.3 years; HbA1c – 63.9 ± 17.5 mmol/mol; serum creatinine – 105.4 ± 45.6 umol/L; haemoglobin – 133 ± 16 mg/dL; vibration perception threshold – 52 ± 25 V; DF in remission – 19/79 (12.7%); chronic Charcot foot – 9/79 patients (11.4%); DF ulcers according to WIfI classification – W1fI0: 35/79 (44.3%), W1fI1: 5/79 (6.3%), W2fI0: 6/ 79 (7.6%), W2fI1: 6/79 (7.6), W3fI1: 8/79 (10.1%); all I 1-2)
DF was defined as infection, ulceration or destruction of foot tissue in individuals with currently or previously diagnosed diabetes mellitus typically accompanied by neuropathy and/or PAD in the lower extremities [13]
Summary
All diagnostic procedures of peripheral arterial disease (PAD) in diabetic foot (DF) are complicated due to diabetes mellitus and its late complications.The aim of our study is to enhance diagnosis of PAD using a novel transcutaneous oximetry (TcPO2) stimulation test. Macrovascular disease is difficult to detect in many DF patients due to the presence of diabetic sensorimotor neuropathy and medial arterial sclerosis in the lower limbs. Autonomic neuropathy, which involves sympathetic denervation affecting the peripheral nerves, leads to the opening of arteriovenous shunts in the microcirculation of the lower limbs as well as alterations in pre-capillary sphincter tone. This group of conditions can result in hypoxia of peripheral tissue even without typical signs of ischaemia, such as cold feet, clinically significant changes in colour and trophic acral lesions [5]. Identifying PAD at this late stage doubles the risk of lower limb amputation in patients with DF [8]
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