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Editorials

Therapeutic Footwear in Diabetes

The good, the bad, and the ugly?

  1. Andrew J.M. Boulton, MD, FRCP12 and
  2. Edward B. Jude, MD, MRCP1
  1. 1Department of Medicine, Manchester Royal Infirmary, Manchester, U.K.
  2. 2Diabetes Research Institute, University of Miami, Miami, Florida
  1. Address correspondence to Andrew J.M. Boulton, MD, FRCP, Department of Medicine, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL, U.K. E-mail: aboulton{at}med.miami.edu
Diabetes Care 2004 Jul; 27(7): 1832-1833. https://doi.org/10.2337/diacare.27.7.1832
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The good, the bad, and the ugly?

In recent years, it has generally been accepted by the diabetes community that “good” footwear prevents foot ulceration. Indeed, it is virtually an axiom of diabetes care that a patient with a history of foot ulcer is a footwear patient for life (1). Similarly, most health care professionals believe that “bad” footwear is a major cause of ulceration in diabetes and that in the past, the fact that most therapeutic footwear was perceived as “ugly” resulted in poor compliance when such footwear was prescribed (2). Where is the evidence to support these beliefs? The last two points are easier dealt with than the first.

There are studies that support the belief that bad or inappropriate footwear causes ulceration. Apelqvist et al. (3) identified shoes as the precipitating cause in the majority of toe ulcers and a significant minority of lesions elsewhere on the foot. In another European study (4), footwear was implicated as being contributory to 21% of all ulcers in a large series.

As we identified in an editorial (5) on the same subject 3 years ago, compliance with regular wearing of the footwear is a major problem. In our U.K. center, when provided with therapeutic footwear free of charge, only 22% of patients admitted that they regularly wore the shoes (2). Similar problems have been reported in the U.S. (6).

It is unclear whether a patient’s perception of such footwear as being “ugly” or cosmetically unattractive is a major contributory factor to this nonadherence behavior. Another factor may be the patient’s belief that the home environment is safe; in a study using continuous activity monitoring, Armstrong et al. (7) reported that “high-risk” patients were much less likely to wear their prescribed footwear when at home than when outside. As such patients are more active when in the home (7), this nonadherence may well be important in the causation of ulcers. The same authors (8) recently confirmed that even patients with active foot ulcers do not regularly wear removable cast walkers when advised to do so.

In the current issue of Diabetes Care, Maciejewski et al. (9) attempt to answer the first point in a structured literature review; that is, can therapeutic footwear prevent the occurrence of ulceration? As no studies have assessed footwear in the primary prevention of ulcers (1), Maciejewski et al. review those reports on the prevention of ulcer recurrence. They identified nine studies from a Medline search and determined that in six of them, footwear was a primary intervention, and in three, it was part of a multifactorial intervention. Each study was rated according to the study design and internal consistency. They conclude in this review that although protective benefit was found, a number of these studies may have been influenced by design issues.

It is perhaps a little unfortunate that the only study that was assigned a study design rating of 1 was by the same authors as those who conducted the review (10). However, having reviewed all of the works, we would entirely agree that the study of Reiber et al. (10) was carefully and appropriately designed and thus warranted a level 1 rating. This study could find no benefits of therapeutic footwear over the patients’ own shoes. In an exchange of correspondence in the literature following the publication of this trial (11–13), surprise was expressed that >40% of patients with an ulcer history had normal peripheral sensation. Moreover, the definition of an ulcer as a lesion that did not heal within 30 days was also a point of discussion. In their reply, Reiber et al. (13) reported that a subset analysis of those patients with sensory loss similarly showed no benefit of therapeutic shoes.

Where does this discussion position us with regard to specialist footwear in 2004? Some years ago, Janisse (14) reviewed “the art and science of footwear design”—at that time it was more art than science. More than 10 years later, the words of Jeffcoate and Harding (15) suggest that little has changed when they concluded about diabetic foot care in general that “clinical practice is based more on opinion than scientific fact.”

There can be little doubt that there is an urgent need for well-designed studies of footwear in both the primary as well as the secondary prevention of neuropathic foot ulceration. Evidence from the literature as reviewed briefly above and by Maciejewski et al. (9) in this issue remains equivocal. Surely, in the 21st century we should be moving toward computer-aided design and manufacture of footwear. In addition, as recently demonstrated (7,8), modern technology now permits the accurate assessment of compliance with footwear provision, which could potentially remove another confounding variable in such studies.

Whereas bad shoes cause ulcers and “ugly” shoes are likely to remain in the closet, a major effort is required to demonstrate that good shoes do actually benefit our high-risk patients.

Footnotes

  • DIABETES CARE

References

  1. ↵
    Cavanagh PR: Does footwear help to protect the insensate diabetic foot? Int Diabetes Monitor. In press
  2. ↵
    Knowles EA, Boulton AJM: Do people with diabetes wear their prescribed footwear? Diabet Med 13:1064–1068, 1996
    OpenUrlCrossRefPubMedWeb of Science
  3. ↵
    Apelqvist J, Larsson J, Agardh CD: The influence of external precipitating factors and peripheral neuropathy on the development and outcome of diabetic foot ulcers. J Diabetes Complications 4:21–25, 1990
  4. ↵
    MacFarlane RM, Jeffcoate WJ: Factors contributing to the presentation of diabetic foot ulcers. Diabet Med 16:867–870, 1997
    OpenUrl
  5. ↵
    Boulton AJM, Jude EB: Friends of the oppressed foot? (Editorial). Diabetes Care 24:615–616, 2001
    OpenUrlFREE Full Text
  6. ↵
    Litzelman DK, Marriott DK, Vinicor F: The role of footwear in the prevention of foot lesions in patients with NIDDM: conventional wisdom or evidence-based practice? Diabetes Care 20:156–162, 1997
    OpenUrlAbstract/FREE Full Text
  7. ↵
    Armstrong DG, Abu-Rumman PL, Nixon BP, Boulton AJM: Continuous activity monitoring in persons at high risk for diabetes related lower-extremity amputation. J Am Podiatr Med Assoc 91:451–455, 2001
    OpenUrlPubMedWeb of Science
  8. ↵
    Armstrong DG, Lavery LA, Kimbriel HR, Nixon BP, Boulton AJM: Activity patterns of patients with diabetic foot ulceration: patients with active ulceration may not adhere to a standard pressure off-loading regime. Diabetes Care 26:2595–2597, 2003
    OpenUrlAbstract/FREE Full Text
  9. ↵
    Maciejewski ML, Reiber GE, Smith DG, Wallace C, Hayes S, Boyko EJ: Effectiveness of diabetic therapeutic footwear in preventing reulceration. Diabetes Care 27:1774–1782, 2004
    OpenUrlAbstract/FREE Full Text
  10. ↵
    Reiber GE, Smith DG, Wallace C, Sullivan K, Hayes S, Vath C, Maciejewski ML, Yu O, Heagerty PJ, LeMaster J: Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized clinical trial. JAMA 287:2552–2558, 2002
    OpenUrlCrossRefPubMedWeb of Science
  11. ↵
    Cavanagh PR, Boulton AJM, Sheehan P, Ulbrecht JS, Caputo GM, Armstrong DG: Therapeutic footwear in people with diabetes (Letter). JAMA 288:1231, 2002
    OpenUrlCrossRefPubMedWeb of Science
  12. Chantelau E: Therapeutic footwear in people with diabetes (Letter). JAMA 288:1231–1232, 2002
  13. ↵
    Reiber GE, Smith DG, Wallace C, Hayes S, Sullivan K, Maciejewski ML, Yu O: Therapeutic footwear in people with diabetes. JAMA 288:1232–1233, 2002
    OpenUrl
  14. ↵
    Janisse D: The art and science of fitting shoes. Foot Ankle 13:257–262, 1992
    OpenUrlPubMedWeb of Science
  15. ↵
    Jeffcoate WJ, Harding RG: Diabetic foot ulcers. Lancet 361:1545–1551, 2003
    OpenUrlCrossRefPubMedWeb of Science
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Therapeutic Footwear in Diabetes
Andrew J.M. Boulton, Edward B. Jude
Diabetes Care Jul 2004, 27 (7) 1832-1833; DOI: 10.2337/diacare.27.7.1832

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Therapeutic Footwear in Diabetes
Andrew J.M. Boulton, Edward B. Jude
Diabetes Care Jul 2004, 27 (7) 1832-1833; DOI: 10.2337/diacare.27.7.1832
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