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| * Footwear; all major reviews recommend special footwear for patients with a prior ulcer or with foot deformities. One review added neuropathy as an indication for special footwear. The comparison of custom shoes versus well-chosen and well-fitted athletic shoes is not clear. | | * Footwear; all major reviews recommend special footwear for patients with a prior ulcer or with foot deformities. One review added neuropathy as an indication for special footwear. The comparison of custom shoes versus well-chosen and well-fitted athletic shoes is not clear. |
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| ====Clinical Trials====
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| ''Clinical Evidence'' reviewed the topic and concluded "Individuals with significant foot deformities should be considered for referral and assessment for customized shoes that can accommodate the altered foot anatomy. In the absence of significant deformities, high quality well fitting non-prescription footwear seems to be a reasonable option" <ref name="pmid16620415">{{cite journal |author=Hunt D |title=Foot ulcers and amputations in diabetes |journal=Clin Evid |volume= |issue= |pages=455-62 |year= |pmid=16620415 |url = http://clinicalevidence.com/ceweb/conditions/dia/0602/0602_I5.jsp | based on September 2005 search}}</ref>.
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| [[National Institute for Health and Clinical Excellence]] has reviewed the topic and concluded that for patients at "high risk of foot ulcers (neuropathy or absent pulses plus deformity or skin changes or previous ulcer" that "specialist footwear and insoles" should be provided <ref name="webNICE">{{cite web
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| | title = Scope: Management of type 2 diabetes: prevention and management of foot problems (update)
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| | work = Clinical Guidelines and Evidence Review for Type 2 Diabetes: Prevention and Management of Foot Problems
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| | publisher = National Institute for Health and Clinical Excellence
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| | date = 20 February 2003
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| | url = http://www.nice.org.uk/nicemedia/pdf/footcare_scope.pdf
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| | format = PDF
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| | accessdate = 2007-12-04
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| }}</ref>
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| A [[meta-analysis]] by the [[Cochrane Collaboration]] concluded that "there is very limited evidence of the effectiveness of therapeutic shoes" <ref name="pmid10908550">{{cite journal |author=Spencer S |title=Pressure relieving interventions for preventing and treating diabetic foot ulcers |journal=Cochrane Database Syst Rev |volume= |issue= |pages=CD002302 |year= |pmid=10908550 | doi=10.1002/14651858.CD002302}}</ref>. However, the meta-analysis was published before the major trial that is in the table below.
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| The major [[randomized controlled trial]] of specialized footwear show no benefit in patients with a prior foot ulceration (see table below).<ref name="pmid12020336">{{cite journal| author=Reiber GE, Smith DG, Wallace C, Sullivan K, Hayes S, Vath C et al.| title=Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial. | journal=JAMA | year= 2002 | volume= 287 | issue= 19 | pages= 2552-8 | pmid=12020336 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=12020336 }} </ref> A prior, smaller, non-randomized trial that showed benefit of custom foot wear in patients with a prior foot ulceration.<ref name=pmid8721941">{{cite journal |author=Uccioli L, Faglia E, Monticone G, Favales F, Durola L, Aldeghi A, Quarantiello A, Calia P, Menzinger G |title=Manufactured shoes in the prevention of diabetic foot ulcers |journal=Diabetes Care |volume=18 |issue=10 |pages=1376-8 |year=1995 |pmid=8721941}}</ref>. In this trial, the [[number needed to treat]] was 4 patients.
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| {| class="wikitable"
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| |+ [[Randomized controlled trial]]s of interventions to prevent complications of diabetic foot.<ref name="pmid12020336">{{cite journal| author=Reiber GE, Smith DG, Wallace C, Sullivan K, Hayes S, Vath C et al.| title=Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial. | journal=JAMA | year= 2002 | volume= 287 | issue= 19 | pages= 2552-8 | pmid=12020336 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=12020336 }} </ref> <ref name="pmid8498761">{{cite journal| author=Litzelman DK, Slemenda CW, Langefeld CD, Hays LM, Welch MA, Bild DE et al.| title=Reduction of lower extremity clinical abnormalities in patients with non-insulin-dependent diabetes mellitus. A randomized, controlled trial. | journal=Ann Intern Med | year= 1993 | volume= 119 | issue= 1 | pages= 36-41 | pmid=8498761 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=8498761 }} </ref> <ref name="pmid9472868">{{cite journal| author=McCabe CJ, Stevenson RC, Dolan AM| title=Evaluation of a diabetic foot screening and protection programme. | journal=Diabet Med | year= 1998 | volume= 15 | issue= 1 | pages= 80-4 | pmid=9472868 | doi=10.1002/(SICI)1096-9136(199801)15:1<80::AID-DIA517>3.0.CO;2-K | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=9472868 }} </ref> <ref name="pmid18758747">{{cite journal| author=Lincoln NB, Radford KA, Game FL, Jeffcoate WJ| title=Education for secondary prevention of foot ulcers in people with diabetes: a randomised controlled trial. | journal=Diabetologia | year= 2008 | volume= 51 | issue= 11 | pages= 1954-61 | pmid=18758747 | doi=10.1007/s00125-008-1110-0 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18758747 }} </ref>
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| ! rowspan="2"|Trial!!rowspan="2"| Patients!!rowspan="2"| Intervention!!rowspan="2"|Comparison !!rowspan="2"|Outcome!!colspan="2"|Results!!rowspan="2"|Comment
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| ! Intervention!!Control
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| | Litzelman<ref name="pmid8498761"/><br/>1993|| 395 patients<br/>• general medicine practice|| Patient and provider education||Usual care||• Any foot lesion<br/> • Serious foot lesions at one year|| Not reported||• 11%<br/>• 2.9%||<br/>• Insignificant <br/>• Significant reduction
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| | Lincoln<ref name="pmid18758747"/><br/>2008|| 172 patients<br/>• Prior ulceration<br/>• specialist clinic|| Targeted, one-to-one education ||Usual care||Re-ulceration at<br/>• 1 year<br/>2 years|| • 30%<br/>• 41%||• 20%<br/>• 41%||• Insignificant<br/>• Insignificant
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| | McCabe<ref name="pmid9472868"/><br/>1998|| 2002 patients<br/>• high-risk<br/>• general diabetic clinic|| Screening and referral to foot-care clinic if they had prior ulcer, had low ankle–brachial index (<0.75), or had foot deformities||Usual care||• Ulceration within 2 years<br/>• Amputation rates|| • 2%<br/>• 0.1%|| 4%<br/>1.2%||• Insignificant<br/>• Significant
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| | Reiber<ref name="pmid12020336"/><br/>2002|| 400 patients<br/>• Prior ulceration<br/>• Excluded severe deformity||Therapeutic shoes||Usual footwear|| Re-ulceration || 15%|| 17%|| Insignificant difference
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| |}
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| ==External Links== | | ==External Links== |
