The other frequently reported method is the biothesiometer. This is a h<strong>and</strong>held devicewhich vibrates at 100Hz <strong>and</strong> connects by an electrical cord to a base unit whichallows the voltage to be <strong>in</strong>creased by the operator through a range <strong>of</strong> 0 to 50V whichis displayed on a scale. This <strong>in</strong>strument is popular <strong>in</strong> specialist diabetes units but is<strong>in</strong>frequently used <strong>in</strong> the primary care sett<strong>in</strong>g.<strong>Foot</strong> exam<strong>in</strong>ation <strong>of</strong> people with diabetes is <strong>of</strong>ten <strong>in</strong>adequate. One study <strong>of</strong> peopleadmitted to a teach<strong>in</strong>g hospital with diabetes foot problems reported that less than15% received a m<strong>in</strong>imally competent lower limb exam<strong>in</strong>ation as part <strong>of</strong> their rout<strong>in</strong>ecare (Armstrong et al, 1998).Evidence – <strong>Detection</strong> <strong>of</strong> Loss <strong>of</strong> Protective <strong>Foot</strong> SensationLoss <strong>of</strong> sensation to the 10g Semmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament predicts footulceration <strong>and</strong> amputationIn a systematic review, Mayfield <strong>and</strong> Sugarman (2000) identified 6 prospectivestudies us<strong>in</strong>g the 10g Semmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament <strong>and</strong> 4 us<strong>in</strong>g VPT to predictthe risk <strong>of</strong> foot ulceration <strong>and</strong> amputation. Among people who were unable to feel theSemmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament which was tested <strong>in</strong> 1 to 4 sites <strong>in</strong>clud<strong>in</strong>g theplantar surface <strong>of</strong> the toes, metatarsal heads, <strong>in</strong>sole, <strong>and</strong> heel, <strong>and</strong> the dorsum <strong>of</strong> thefoot, the odds ratio (OR) <strong>of</strong> <strong>in</strong>creased risk <strong>of</strong> ulceration ranged from 4.1 (CI 1.89-8.87) to 18.4 (CI 3.83-88.47), <strong>and</strong> the relative risk (RR) <strong>of</strong> amputation ranged from2.2 (CI 1.5-3.1) to 9.9 (CI 4.8-21.0). Similarly, the risk <strong>of</strong> ulceration <strong>in</strong>creased <strong>in</strong>people with VPT >25, with an OR rang<strong>in</strong>g from 4.4 (CI 1.1-17.3) to 10.8 (CI 4.6-25.7).The follow<strong>in</strong>g provides more details on studies <strong>in</strong>cluded <strong>in</strong> the above systematicreview. In prospective studies, the 10g Semmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament has emergedas the most sensitive test for peripheral neuropathy <strong>in</strong> predict<strong>in</strong>g foot ulcer risk.Boyko <strong>and</strong> coworkers (1999) studied 749 US veterans with diabetes who werefollowed up for a mean <strong>of</strong> 3.7 years. 163 ulcers developed dur<strong>in</strong>g the follow-up. Therisk <strong>of</strong> develop<strong>in</strong>g a foot ulcer was significantly higher for <strong>in</strong>ability to perceive the10g Semmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament at one or more <strong>of</strong> 9 sites (RR 3.37, CI 2.45-4.63; p
tendon reflexes (OR 6.48, CI 2.37–18.06), while absent vibration sensation was not asignificant <strong>in</strong>dependent risk factor (McNeely et al, 1995).In another prospective study <strong>of</strong> native American Indians, sensory status wasdeterm<strong>in</strong>ed by the 10g Semmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament applied to 8 po<strong>in</strong>ts on theplantar surface <strong>of</strong> each foot. The 358 subjects were bl<strong>in</strong>dfolded <strong>and</strong> retested twicebefore be<strong>in</strong>g classified as <strong>in</strong>sensate (if they consistently failed to feel the filament atone or more locations). 68 subjects were unable to feel the mon<strong>of</strong>ilament at screen<strong>in</strong>g.Among this group, there was a significantly <strong>in</strong>creased risk <strong>of</strong> subsequent ulceration(OR 9.9, CI 4.8-21.0) <strong>and</strong> amputation (OR 17, CI 4.5-95.0) compared with those whoreta<strong>in</strong>ed sensation (Rith-Najarian et al, 1992).In another case-control, 30 people with recent or current foot ulceration werecompared with 85 controls without a history <strong>of</strong> foot ulcer (Armstrong et al, 1998).The sensitivity <strong>and</strong> specificity <strong>of</strong> VPT test<strong>in</strong>g assessed us<strong>in</strong>g a biothesiometer, the 10gSemmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament <strong>and</strong> a 4-question verbal neuropathy score werecompared. Overall, VPT > 25V or four or more <strong>of</strong> eight imperceptible mon<strong>of</strong>ilamentsites had higher sensitivity (100%) <strong>and</strong> specificity (76.5%) than the symptom score.However comb<strong>in</strong><strong>in</strong>g the modalities <strong>in</strong>creased specificity (88.2%) but sensitivitydecreased to 88.2%. Armstrong <strong>and</strong> coworkers recommend the mon<strong>of</strong>ilament as an<strong>in</strong>expensive <strong>and</strong> reliable method for use <strong>in</strong> primary care, nurs<strong>in</strong>g or specialist practice.The different screen<strong>in</strong>g techniques to identify diabetic people at high risk <strong>of</strong> footulceration were compared by Pham <strong>and</strong> coworkers (2000) <strong>in</strong> 248 people who werefollowed up for 30 months. <strong>Foot</strong> ulcers developed <strong>in</strong> 73 people or 95 feet dur<strong>in</strong>g thestudy. People with foot ulcer were more likely to be <strong>in</strong>sensate to the 10g Semmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament (p=0.000), had a higher neuropathy symptom score (NDS)(p=0.000), a high VPT (p=0.000), <strong>and</strong> high foot pressure (p=0.000) compared withpeople who did not develop a foot ulcer. Of these techniques, <strong>in</strong>ability to feel themon<strong>of</strong>ilament comb<strong>in</strong>ed with high NDS had a sensitivity <strong>of</strong> 99% for foot ulcerdevelopment, while the best specificity <strong>of</strong> 78% was seen with the comb<strong>in</strong>ation <strong>of</strong> highNDS <strong>and</strong> foot pressure. A multivariate analysis showed that significant factors fordevelop<strong>in</strong>g foot ulcer were high NDS (OR 3.1, CI 1.3-7.6, p=0.013), high VPT (OR3.4, CI 1.7-6.8, p=0.001), <strong>in</strong>ability to detect the mon<strong>of</strong>ilament (OR 2.4, CI 1.1-5.3,p=0.036), <strong>and</strong> high foot pressure (OR 2.0, CI 1.2-3.3, p=0.007). The authorsconcluded that cl<strong>in</strong>ical exam<strong>in</strong>ation comb<strong>in</strong>ed with test<strong>in</strong>g with the 10g Semmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament is the most sensitive test <strong>in</strong> identify<strong>in</strong>g people at high risk forfoot ulceration.The 10g Semmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament is cl<strong>in</strong>ically reliableIn 1,001 people attend<strong>in</strong>g a UK diabetes cl<strong>in</strong>ic, foot exam<strong>in</strong>ation was performed withthe 10g Semmes-We<strong>in</strong>ste<strong>in</strong> mon<strong>of</strong>ilament, biothesiometer <strong>and</strong> pulse palpation(Klenerman et al, 1996). 229 people with an <strong>in</strong>itial abnormal test were <strong>in</strong>vited for asecond test. Of this group, 21.8% had loss <strong>of</strong> protective sensation as judged by theabsence <strong>of</strong> some or all protective sensation to the mon<strong>of</strong>ilament; 7.7% had absentpedal pulses <strong>and</strong> 4% had comb<strong>in</strong>ed vascular <strong>and</strong> sensory loss. Between the twotest<strong>in</strong>gs the biothesiometer variation was considered cl<strong>in</strong>ically unacceptable. Theresults for palpation <strong>of</strong> pedal pulses were more stable, with 81% <strong>of</strong> people hav<strong>in</strong>g thesame results for the posterior tibial pulse on the right, compared to 70% on the left43
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