PVD in diabetes

NewsBot · Apr 22, 2006

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An Evaluation of the Efficacy of Methods Used in Screening for Lower-Limb Arterial Disease in Diabetes.
Perspect Vasc Surg Endovasc Ther. 2006 Mar;18(1):81

Lower-limb peripheral arterial occlusive disease (PAOD) is a common cause of hospital admission among patients with diabetes. The authors conducted a study of 130 limbs in 68 patients with and without diabetes mellitus to evaluate the accuracy of methods used to screen for PAOD and peripheral neuropathy, including foot pulses and the ankle-brachial or toe-brachial pressure index, and Doppler waveform analysis. They determined that the screening tools of foot pulses, toe-brachial pressure index and qualitative waveform analysis were highly sensitive screening methods in patients as long as peripheral neuropathy was not present. Qualitative waveform analysis and the toe-brachial index were more effective in high-risk limbs with detectable peripheral neuropathy.
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Admin2 · Apr 22, 2006

Peripheral vascular disease

Related threads:
Eficacy of screening for PVD in diabetes
Improving accuracy of ankle-arm index
Toe Brachial Index
Laser therapy for PVD in diabetes

NewsBot · Aug 26, 2006

The influence of diabetes and lower limb arterial disease on cutaneous foot perfusion.
J Vasc Surg. 2006 Aug 22;
Williams DT, Price P, Harding KG

OBJECTIVE: Peripheral arterial occlusive disease and peripheral neuropathy are major risk factors in diabetic foot disease. We evaluated the relative influences of noncritical lower limb arterial disease and peripheral neuropathy on cutaneous foot perfusion in diabetes.

METHOD: Toe-brachial pressure indices, transcutaneous oxygen, and carbon dioxide tensions at foot and chest sites were measured in individuals with diabetes, with or without detectable peripheral neuropathy and with or without significant arterial disease on color duplex imaging. Subjects without diabetes, with and without arterial disease, were used as controls.

RESULTS: A total of 130 limbs were studied during an 8-month period. Toe-brachial pressure indices reflected the presence of arterial disease in all groups. Foot transcutaneous oxygen values were reduced in diabetes and correlated with chest transcutaneous oxygen values. Low foot transcutaneous oxygen with elevated transcutaneous carbon dioxide values were only demonstrated in individuals with diabetes, arterial disease, and peripheral neuropathy. Toe-brachial pressure indices demonstrated a positive correlation with foot transcutaneous oxygen values, but values >1.2 demonstrated a negative correlation.

CONCLUSIONS: We demonstrated two influences on cutaneous foot perfusion in diabetes: (1) a global microcirculatory dysfunction, reflected in low chest and foot transcutaneous oxygen values, and (2) macrovascular disease as indicated by reduced toe-brachial pressure indices and foot transcutaneous oxygen values. Further, the results demonstrated that in diabetic individuals without critical limb ischemia, impaired foot perfusion secondary to arterial disease is amplified significantly by coexisting microcirculatory disease.
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markjohconley · Nov 9, 2006

any one know ........ are tbi's potentially as invasive as abi's in dislodging emboli from thrombi (re. use of cuffs) ie can digital arteries be atherosclerotic? and do the sound waves of doppler u/s have invasive properties, again dislodging emboli (also relevant to performing lower leg arterial waveform analyses)? ... thanks, mark c

Asher · Apr 21, 2008

Hi Mark

markjohconley said: ↑

any one know ........ are tbi's potentially as invasive as abi's in dislodging emboli from thrombi (re. use of cuffs) ie can digital arteries be atherosclerotic? and do the sound waves of doppler u/s have invasive properties, again dislodging emboli (also relevant to performing lower leg arterial waveform analyses)? ... thanks, mark c
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I've been reading the archives. I'm interested in the answer to your question also.

It seems the ABI is the test that podiatrists can do in detecting the degree of peripheral arterial disease (PAD). How much of a risk is the use of the cuff to embolism? I have read quite a bit on the subject of ABI recently and I have not come across any mention of it.

Rebecca

NewsBot · Jun 18, 2008

Impact of peripheral arterial disease in patients with diabetes-Results from PROactive (PROactive 11).
Dormandy JA, Betteridge DJ, Schernthaner G, Pirags V, Norgren L; on behalf of the PROactive investigators.
Atherosclerosis. 2008 Mar 18. [Epub ahead of print]

We compared cardiovascular disease outcomes according to the presence of peripheral arterial disease (PAD) at baseline in a post hoc analysis from the PROactive study. Of the 5238 patients in PROactive (a study of pioglitazone versus placebo in patients with type 2 diabetes and macrovascular disease; mean follow-up=34.5 months), 1274 had PAD at baseline (619=pioglitazone; 655=placebo). Patients with PAD at baseline showed significantly higher rates of the primary endpoint, main secondary endpoint, all-cause mortality (all P<0.0001), and stroke (P=0.0175) than those with no PAD at baseline. The risk of PAD alone was similar to that of myocardial infarction alone. In patients with no PAD at baseline, the event rates of the primary endpoint (P=0.0160), main secondary endpoint (P=0.0453), and acute coronary syndrome (P=0.0287) were significantly lower with pioglitazone than with placebo. This beneficial effect of pioglitazone was not seen in patients with PAD at baseline. In the total population, there was a higher frequency of leg revascularizations with pioglitazone than placebo-this was wholly due to first events that occurred within the initial 12 months of treatment. The presence of PAD increased the risk of all major cardiovascular events. Those without PAD at baseline seemed to benefit more from pioglitazone treatment than the overall PROactive population.
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Mart · Jun 18, 2008

markjohconley said: ↑

and do the sound waves of doppler u/s have invasive properties, again dislodging emboli (also relevant to performing lower leg arterial waveform analyses)? ... thanks, mark c
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My understanding of the potentialy harmful tissue effects of US are that it is less to do with the vibrational effects of the sound waves but more the effects of cavitation (creation of gas bubbles created within body fluids). Diagnostic US equipement is designed to limit energy output below body tissue cavitation levels as opposed to therapeutic US which is designed to allow this. When you use your US cleaner for your instruments or tissue debridement it is the bubbles created by the vibrations which do the work not the sound waves themselves.

cheers

Martin

The St. James Foot Clinic
1749 Portage Ave.
Winnipeg
Manitoba
R3J 0E6
phone [204] 837 FOOT (3668)
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www.winnipegfootclinic.com

NewsBot · Jun 18, 2008

Sub-clinical vascular disease in type 2 diabetic subjects: relationship with chronic complications of diabetes and the presence of cardiovascular disease risk factors.
Mostaza JM, Suarez C, Manzano L, Cairols M, López-Fernández F, Aguilar I, Diz Lois F, Sampedro JL, Sánchez-Huelva H, Sanchez-Zamorano MA,
Eur J Intern Med. 2008 Jun;19(4):255-60

BACKGROUND: We evaluated the association between a low ankle-brachial index (ABI), chronic complications of diabetes, and the presence of traditional cardiovascular disease risk factors in subjects with type 2 diabetes but without known cardiovascular disease.

METHODS: We included diabetic subjects (n=923; 52% male; age range 50-85 years) without clinical evidence of coronary, cerebrovascular, or peripheral artery disease (PAD). A history of nephropathy, retinopathy, or neuropathy was collected from the medical records. A 12-lead electrocardiogram and ABI measurements were conducted on all study participants.

RESULTS: The mean duration of diabetes was 9.6 years. Prevalence of a low ABI (<0.9) was 26.2%. Multivariate analysis indicated that factors significantly associated with a low ABI were age (OR: 1.06; 95%CI: 1.033-1.084; p<0.001), plasma triglyceride concentration (OR: 1.002; 95%CI: 1.001-1.004; p=0.006), duration of diabetes (OR: 1.029; 95%CI: 1.008-1.051; p=0.007), and smoking habit (OR: 1.755; 95%CI: 1.053-2.925; p=0.03). The presence of nephropathy, neuropathy, retinopathy, left ventricular hypertrophy, left bundle branch block, and atrial fibrillation were all associated with a low ABI, but only renal disease remained significant after adjusting for age, duration of diabetes, and cardiovascular risk factors.

CONCLUSION: A low ABI is highly prevalent in subjects with diabetes and is related to age, duration of diabetes, smoking habit, and hypertriglyceridemia. Although chronic complications are frequently associated with a low ABI, only renal damage is independently associated with peripheral artery disease.
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NewsBot · Aug 19, 2008

Prevalence of peripheral arterial disease in patients with diabetes mellitus in a primary care setting.
Rabia K, Khoo EM.
Med J Malaysia. 2007 Jun;62(2):130-3.

The aims of the study were to determine the prevalence of peripheral arterial disease (PAD) in diabetic patients and in different ethnic groups at a primary care setting, and to evaluate risk factors associated with PAD in these diabetic patients. A cross sectional study of 200 diabetic patients over 18 years old who attended a primary care clinic at a teaching hospital in Kuala Lumpur, Malaysia was carried out. Face-to-face interviews were conducted using structured questionnaires for demographic characteristics and risk factors evaluation. Blood pressure measurements, assessment of peripheral neuropathy and ankle brachial pressures were performed. PAD was diagnosed by an ankle brachial pressure index (ABPI) of <0.9 on either leg. The overall prevalence of PAD was 16% in this diabetic population. The prevalence of PAD was 5.8% in Malays, 19.4% in Chinese and 19.8% in Indians. The prevalence of peripheral neuropathy was 41%, foot ulcer 9.5%, and gangrene 3.0%. The presence of foot ulcer was weakly associated with PAD (P=0.052). No significant relationships were found between age, gender, smoking status, duration of diabetes mellitus, hypertension, dyslipidaemia, and PAD. PAD is common in the diabetic population of this study.
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NewsBot · Jan 17, 2009

The association between diabetes mellitus and the prevalence of intermittent claudication: the HUNT study.
Jensen SA, Vatten LJ, Myhre HO.
Vasc Med. 2008 Nov;13(4):239-44.

The objective of this study was to investigate the association between diabetes mellitus (DM) and the prevalence of intermittent claudication (IC). Between 1995 and 1997, all residents aged 20 years or older in Nord-Trøndelag County, Norway were mailed an invitation to participate in a health survey (HUNT 2). A total of 19,712 participants aged 40-69 years old completed and returned the questionnaire included with the invitation. They also attended an examination where brachial blood pressure was measured and non-fasting venous blood was collected. The venous blood sample was subsequently analysed for concentrations of blood lipids. Responses to 12 questions on IC were previously tested against ankle blood pressure measurements (ABPI < 0.9) and the algorithm with the best test properties was used to identify individuals with IC. Participants reported a history of DM by simple questions in the questionnaire. Logistic regression analysis was then used to compute age-adjusted prevalence odds ratios for the association between exposure variables and the prevalence of IC. Potential confounding by smoking, blood lipids and brachial blood pressure was investigated in multivariate analyses. For both sexes IC was more common in individuals with DM (OR(women) = 3.8, CI, 1.9-7.6; OR(men) = 2.8, CI, 1.4-5.8) compared to participants without DM. Adjustment for smoking, blood lipids and brachial blood pressure did not substantially change these results. In conclusion, the prevalence of IC was more than three times higher in patients with DM compared to non-diabetic participants.
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NewsBot · Jun 6, 2009

The vascular and biochemical effects of cilostazol in diabetic patients with peripheral arterial disease.
O'Donnell ME, Badger SA, Sharif MA, Makar RR, Young IS, Lee B, Soong CV.
Vasc Endovascular Surg. 2009 Apr-May;43(2):132-43.

OBJECTIVES: Cilostazol improves walking in patients with peripheral arterial disease (PAD). We hypothesized that cilostazol reduces diabetic complications in PAD patients. METHODS: Diabetic PAD patients were prospectively recruited to a randomized double-blinded, placebo-controlled trial, using cilostazol 100mg twice a day. Clinical assessment included ankle-brachial index, arterial compliance, peripheral transcutaneous oxygenation, treadmill walking distance and validated quality of life (QoL) questionnaires. Biochemical analyses included glucose and lipid profiles. All tests were at baseline, 6, and 24 weeks. RESULTS: 26 diabetic PAD patients (20 men) were recruited. Cilostazol improved absolute walking distance at 6 and 24 weeks (86.4% vs. 14.1%, P = .049; 143% vs. 23.2%, P = .086). Arterial compliance and lipid profiles improved as did some QoL indices for cilostazol at 6 and 24 weeks. Blood indices were similar at baseline and at follow-up points for both treatment groups. CONCLUSIONS: Cilostazol is a well-tolerated and efficacious treatment, which improves claudication distances in diabetic PAD patients with further benefits in arterial compliance, lipid profiles, and QoL.
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NewsBot · Oct 30, 2009

Polydeoxyribonucleotide (PDRN): A Safe Approach to Induce Therapeutic Angiogenesis in Peripheral Artery Occlusive Disease and in Diabetic Foot Ulcers.
Altavilla D, Bitto A, Polito F, Marini H, Minutoli L, Di Stefano V, Irrera N, Cattarini G, Squadrito F.
Cardiovasc Hematol Agents Med Chem. 2009 Oct;7(4):313-21.

Peripheral arterial occlusive disease (PAOD) of lower extremities is becoming more prevalent worldwide. The general prognosis is particularly negative with a high prevalence of coronary heart disease and cerebrovascular disease. Diabetic foot ulcers occur in 15% of all the patients with diabetes and proceed to lower-leg amputations. In diabetic ulcers, wound healing is impaired because of delayed angiogenesis. In both pathological conditions, therapeutic angiogenesis using angiogenic growth factors, particularly Vascular Endothelial Growth Factor VEGF, is expected to be a valuable treatment. The most used approaches are based on VEGF local delivery or gene therapy, but they failed to meet the expected primary goals of therapy. Adenosine receptor stimulation can induce VEGF expression in many types of cells and this may be achieved by stimulating the A(2A) or A(2B) receptor or both, following the signalling pathways activated by hypoxia. Polideoxyribonucleotide (PDRN) is obtained from sperm trout by an extraction process. The compounds hold a mixture of deoxyribonucleotides polymers with chain lengths ranging between 50 and 2000 bp. PDRN is able to stimulate VEGF production during pathological conditions of low tissue perfusion. It likely acts through the stimulation of A(2A) receptors. Furthermore, acute and chronic toxicity studies showed a good safety profile. PDRN has been shown to be effective in an experimental model of PAOD, hind limb ischemia, impaired wound healing and burn injury. Preliminary studies and ongoing clinical trials predict a significant therapeutic efficacy in patients. These data lead to hypothesize a role for PDRN in therapeutic angiogenesis.
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NewsBot · Oct 19, 2010

An assessment of peripheral vascular disease in patients with diabetic foot ulcer.
Ikem R, Ikem I, Adebayo O, Soyoye D.
Foot (Edinb). 2010 Oct 14. [Epub ahead of print]

BACKGROUND: Peripheral vascular disease (PVD) is a chronic limb ischaemia caused by atherosclerosis of the peripheral arteries. Diabetes mellitus is a risk factor for this disease. The most common symptom of PVD is muscle pain in the lower limbs on exercise. In diabetes, pain perception may be blunted by the presence of peripheral neuropathy. Therefore, a patient with diabetes and PVD is more likely to present with an ischaemic ulcer or gangrene than a patient without diabetes. The use of ankle-brachial-pressure index (ABI) in the clinic and bedside provide a measure of blood flow to the ankle. This could help early detection, initiate early therapy and may thus reduce the risk of critical limb ischaemia and limb loss.

OBJECTIVE: The purpose of this study is to evaluate the occurrence of peripheral vascular disease using ankle-brachial index in diabetic patients with and without foot ulcers and the risk factors associated with diabetic foot ulcer (DFU).

METHOD: This prospective study involved all type 2 DM patients with foot ulcer (DFU population) and those without foot ulcers (non-DFU population) seen in our hospital. Their demographic, clinical and laboratory parameters were noted and documented. Measurement of ABI was done using a portable hand held Doppler and ankle pressures<0.9 is suggestive of PVD.

RESULTS: A total of 74 patients were recruited. Males were 42 (56.8%) and females were 32 (43.2%). The mean age of the patients was 62.89±10.66 years and the duration of diabetes was 7.61±7.57 years. Forty-six (62.2%) presented with foot ulcer while 28 (37.8%) were without foot ulcer. Patients with PVD represented by ABI<0.9 was DFU 31(76.4%) while in non-DFU it was 10 (13.4%). Multivariant analysis of variables associated with DFU in those with ABI<0.9 showed correlation with tobacco use r=.235, p=0.044; duration of diabetes r=-.427; p=0.001; and systolic blood pressure r=-.301; p=0.009.

DISCUSSION: The occurrence of PVD determined by the absence of >2 pulses by palpation alone and using ABI was 25.7% and 55.4% respectively. This suggests that assessment by palpation is subjective while the use of Doppler is quantitative and more reliable. DFU patients with PVD showed a significant correlation with tobacco use, duration of diabetes and systolic blood pressure but not with dyslipidaemia.

CONCLUSION: This study shows that these patients had risk factors for PVD. The use of hand held Doppler will aid early diagnosis of critical limb at risk of loss and help to prevent and reduce the high rate of limb loss in our patients.
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NewsBot · May 16, 2013

Cilostazol prevents foot ulcers in diabetic patients with peripheral vascular disease.
de Franciscis S, Gallelli L, Battaglia L, Molinari V, Montemurro R, Stillitano DM, Buffone G, Serra R.
Int Wound J. 2013 May 15.

Diabetic patients are at the high risk of foot ulcerations that may lead to limb amputations with important socio economic impact. Peripheral vascular disease may be frequently associated in diabetes mellitus type II with its main symptom, intermittent claudication. Many studies reported the known efficacy of cilostazol in treating vascular claudication. Metalloproteinase-9 (MMP-9) seems to be a biochemical marker implicated in chronic wounds and in particular in diabetic foot ulcers. Cilostazol seems to have also a lowering effect on levels of MMP-9 and this may suggest a beneficial effect in order to prevent or retard the onset of foot ulcer in diabetic patients. In our study two groups of diabetic patients, with peripheral vascular disease were divided into two groups according to the presence of claudication in order to receive cilostazol. Group A (31 patients without claudication) were not eligible to receive cilostazol whereas Group B (47 patients with claudication) received cilostazol administration for 24 weeks (100 mg orally twice daily). Median follow up was of 16 months. During the follow up 4·25% of patients of Group B and 35·48% of patients of Group A (P < 0·01) showed the onset of foot ulceration. Although further randomised and controlled studies are required cilostazol seems to show beneficial effects for primary prevention of diabetic foot ulcers.
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NewsBot · Jan 30, 2019

Association of diabetic foot ulcers with chronic vascular diabetic complications in patients with type 2 diabetes
Magdy H.MegallaaAzza A.IsmailMohammed H.ZeitounMai S.Khalifa
Diabetes & Metabolic Syndrome: Clinical Research & Reviews 24 January 2019

Context
Diabetes mellitus is a common disease which is prevalent globally, presenting with chronic complications and constitutes a major risk to the patient. Diabetic foot ulcers are the single biggest risk factor for non-traumatic foot amputations in persons with diabetes. We aimed to screen the chronic vascular diabetic complications in patients with diabetic foot ulcers (DFU) and to assess the association of diabetic foot ulcers with these complications in the study group.

Subjects
And Methods: This cross-sectional study included 180 type 2 diabetic patients (aged 30–70 years) with diabetic foot ulcer who attended the outpatient clinic of Diabetes in Alexandria Main University hospital. Full diabetic foot examination was done to all study subjects. DFU was assessed using University Of Texas Diabetic Wound Classification System. HbA1c, LDL-C, serum creatinine, and urinary albumin creatinine ratio (ACR) were measured for all study subjects. Estimated glomerular filtration rate (eGFR) was calculated using CKD-EPI equation. Fundus examination was done for all study subjects.

Results
The prevalence of diabetic kidney disease (DKD) and diabetic retinopathy (DR) was 86.1% and 90% respectively among the study group. 86.7% of patients had neuropathic DFU, 11.1% of them had ischemic DFU and 2.2% had neuro-ischemic DFU. Regarding diabetic peripheral neuropathy (DPN) and peripheral arterial disease (PAD) as risk factors for developing DFU, the prevalence of both of them respectively was 82% and 20% among the study group. There was statistically significant association between both DKD, DR and peripheral neuropathy. Also there was statistically significant association between both DKD, DR and peripheral arterial disease.

Conclusion
Chronic vascular diabetic complications are common among type 2 diabetic patients with diabetic foot ulcers. There is statistically significant association between these complications and diabetic peripheral neuropathy (DPN) and peripheral arterial disease (PAD)
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NewsBot · Jul 30, 2020

Comparison of the effects of cilostazol and aspirin on wound healing in patients with diabetic foot ulcer and peripheral artery disease
Bayram Colak, Atilla Orhan, Ilhan Ece, Serdar Yormaz, Huseyin Yilmaz, Mustafa Sahin
Ann Ital Chir. 2020;91:225-232.

Diabetic foot ulcer (DFU) is one of the most feared complications of diabetes mellitus. Studies report that the lifetimerate of developing DFU is 25% for patients with diabetes mellitus. In addition, peripheral artery disease (PAD) is seen in approximately 50% of patients with DFU. PAD increases the risk of amputation in patients with DFU and complicates treatment. This study aimed to compare the effects of cilostazol and aspirin on wound healing in patients with DFU and PAD. In the study, DFU patients with PAD were retrospectively reviewed. They were divided into two groups. One group was administeredcilostazoland the other was administeredaspirin. Patients were evaluated according to their demographic characteristics, wound characteristics, PAD symptoms, duration of treatment, and treatment grades. There were 30 patients in the cilostazol group and 20 patients in the aspirin group. Of the patients in the cilostazol group, seven(23.3%) had Wagner's grade 2, 16 (53.3%) had grade 3, and seven (23.3%) had grade 4 DFU. In the aspirin group this rate was 25%, 55%, and 20%, respectively. The mean size of the wound in the cilostazol group was 8.1 cm (2-25 cm), whereas it was 7.6 cm (5-25 cm) in the aspirin group. The mean ankle-brachial index (ABI) of the patients was 0.90 in the cilostazol group and 0.96 in the aspirin group. Five (23.3%) of the patients in the cilostazol group had triphasic, 19 (63.3%) biphasic, and six(20%) monophasic currents in the distal popliteal vein. In the aspirin group, these rates were 35%, 50%, and 20%, respectively. Of the patients in the cilostazol group, according to the Fontaine classification, six(20%) had stage 2A, 11 (36.7%) had stage 2B, 10 (33.3%) had stage 3, and three(10%) had stage 4 symptoms. In the aspirin group, these rates were 45%, 40%, 15%, and 0%, respectively. There was a complete response to treatment in 27 patients (90%) in the cilostazol group and 11 patients (55%) in the aspirin group. Partial response was present in the other patients. The mean duration of treatment was 1.31 months (1-2 months) in the cilostazol group and 1.82 months (1-2.5 months) in the aspirin group. In this study, it was observed that wound healing was faster in the cilostazol group, complete response to treatment was higher, and improvement in PAD symptoms was better compared to the aspirin group
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NewsBot · Jan 18, 2023

Accuracy of the defining characteristics of the nursing diagnosis ineffective peripheral tissue perfusion in patients with diabetic foot
Paula Vitória Costa Gontijo et al
Int J Nurs Knowl. 2023 Jan 17

Objective: To evaluate the accuracy of the defining characteristics of the nursing diagnosis ineffective peripheral tissue perfusion in patients with diabetic foot.

Method: A diagnostic accuracy study with a cross-sectional design was carried out with patients with type 2 diabetes mellitus on outpatient diabetic foot treatment. We evaluated 134 patients with diabetic foot to determine the accuracy of the defining characteristics of ineffective peripheral tissue perfusion. A latent class model with random effects was used to establish the sensitivity and specificity of the defining characteristics assessed.

Results: Ineffective peripheral tissue perfusion was present in 83.79% of the patients. The defining characteristics color does not return to lowered limb after 1-minute leg elevation and edema had high sensitivity (0.8370 and 0.7213) and specificity (0.9991 and 0.9995).

Conclusion: The defining characteristics color does not return to lowered limb after 1-minute leg elevation and edema are good clinical indicators that can be used for screening and confirming ineffective peripheral tissue perfusion in patients with diabetic foot.
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NewsBot · Aug 2, 2023

Effectiveness of bedside investigations to diagnose peripheral artery disease among people with diabetes mellitus: A systematic review
Vivienne Chuter et al
Diabetes Metab Res Rev. 2023 Jul 21

As a progressive disease process, early diagnosis and ongoing monitoring and treatment of lower limb peripheral artery disease (PAD) is critical to reduce the risk of diabetes-related foot ulcer (DFU) development, non-healing of wounds, infection and amputation, in addition to cardiovascular complications. There are a variety of non-invasive tests available to diagnose PAD at the bedside, but there is no consensus as to the most diagnostically accurate of these bedside investigations or their reliability for use as a method of ongoing monitoring. Therefore, the aim of this systematic review was to first determine the diagnostic accuracy of non-invasive bedside tests for identifying PAD compared to an imaging reference test and second to determine the intra- and inter-rater reliability of non-invasive bedside tests in adults with diabetes. A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective and retrospective investigations of the diagnostic accuracy of bedside testing in people with diabetes using an imaging reference standard and reliability studies of bedside testing techniques conducted in people with diabetes were eligible. Included studies of diagnostic accuracy were required to report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio (NLR) which were the primary endpoints. The quality appraisal was conducted using the Quality Assessment of Diagnostic Accuracy Studies and Quality Appraisal of Reliability quality appraisal tools. From a total of 8517 abstracts retrieved, 40 studies met the inclusion criteria for the diagnostic accuracy component of the review and seven studies met the inclusion criteria for the reliability component of the review. Most studies investigated the diagnostic accuracy of ankle -brachial index (ABI) (N = 38). In people with and without DFU, PLRs ranged from 1.69 to 19.9 and NLRs from 0.29 to 0.84 indicating an ABI <0.9 increases the likelihood of disease (but the extent of the increase ranges from a small to large amount) and an ABI within the normal range (≥0.90 and <1.3) does not exclude PAD. For toe-brachial index (TBI), a threshold of <0.70 has a moderate ability to rule PAD in and out; however, this is based on limited evidence. Similarly, a small number of studies indicate that one or more monophasic Doppler waveforms in the pedal arteries is associated with the presence of PAD, whereas tri- or biphasic waveform suggests that PAD is less likely. Several forms of bedside testing may also be useful as adjunct tests and 7 studies were identified that investigated the reliability of bedside tests including ABI, toe pressure, TBI, transcutaneous oxygen pressure (TcPO2 ) and pulse palpation. Inter-rater reliability was poor for pulse palpation and moderate for TcPO2. The ABI, toe pressure and TBI may have good inter- and intra-rater reliability, but margins of error are wide, requiring a large change in the measurement for it to be considered a true change rather than error. There is currently no single bedside test or a combination of bedside tests that has been shown to have superior diagnostic accuracy for PAD in people with diabetes with or without DFU. However, an ABI <0.9 or >1.3, TBI of <0.70, and absent or monophasic pedal Doppler waveforms are useful to identify the presence of disease. The ability of the tests to exclude disease is variable and although reliability may be acceptable, evidence of error in the measurements means test results that are within normal limits should be considered with caution and in the context of other vascular assessment findings (e.g., pedal pulse palpation and clinical signs) and progress of DFU healing.
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