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Neuropathic Diabetic Foot Ulcers
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     To the Editor: Boulton et al. (July 1 issue)1 state that foot ulceration in diabetes is caused by several factors acting together, but particularly by neuropathy. They also assert that direct evidence of a link between glycemic control and healing of neuropathic ulcers is lacking. However, there is good evidence that glycemic control delays the progression of neuropathy.2 I am surprised that glucose control or normalization is not specifically advocated. Furthermore, the American Diabetes Association and others recommend normalization of blood glucose levels as an important component of the prevention and treatment of diabetic foot wounds.3,4,5

    Hernan R. Chang, M.D.

    P.O. Box 17577

    Jacksonville, FL 32245-7577

    hrc8@hotmail.com

    References

    Boulton AJM, Kirsner RS, Vileikyte L. Neuropathic diabetic foot ulcers. N Engl J Med 2004;351:48-55.

    The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-986.

    Mayfield JA, Reiber GE, Sanders LJ, Janisse D, Pogach LM. Preventive foot care in people with diabetes. Diabetes Care 2003;26:Suppl 1:S78-S79.

    American Diabetes Association. Consensus Development Conference on Diabetic Foot Wound Care: 7-8 April 1999, Boston, Massachusetts. Diabetes Care 1999;22:1354-1360.

    Caputo GM, Cavanagh PR, Ulbrecht JS, Gibbons GW, Karchmer AW. Assessment and management of foot disease in patients with diabetes. N Engl J Med 1994;331:854-860.

    To the Editor: Boulton et al. discuss the use of hyperbaric oxygen as an "area of uncertainty." The authors mention that there is a lack of supporting data for this treatment. However, the role of hyperbaric oxygen in the treatment of diabetic wounds has been well investigated. At least 18 different studies, including 6 randomized control trials, show the beneficial effects of hyperbaric oxygen.1,2 Tissue hypoxia, a primary cause of nonhealing, has been documented by transcutaneous or tissue oxygen monitoring, and values of less than 30 mm Hg tend to predict nonhealing.3 The use of hyperbaric oxygen is indicated in situations in which intermittent inhalation of oxygen under pressure reverses tissue hypoxia. Transcutaneous oxygen monitoring at baseline and during treatment with hyperbaric oxygen predicts whether or not hyperbaric oxygen will be effective.4 The Centers for Medicare and Medicaid Services,5 as well as most other insurance carriers, recognizes hyperbaric oxygen as an approved, reimbursable treatment for problematic diabetic wounds.

    Igor V. Aksenov, M.D., Ph.D.

    University of Florida

    Gainesville, FL 32606

    ia@ufl.edu

    References

    Strauss MB. Hyperbaric oxygen as an adjunct to surgical management of the problem wound. In: Bakker DJ, Cramer FS, eds. Hyperbaric surgery: perioperative care. Flagstaff, Ariz.: Best Publishing, 2002:383-96.

    Feldmeier J, ed. Hyperbaric oxygen 2003: indications and results: Hyperbaric Oxygen Therapy Committee report. Kensington, Md.: Undersea & Hyperbaric Medical Society, 2003:41-55.

    Hunt TK, Zederfeldt B, Goldstick TK. Oxygen and healing. Am J Surg 1969;118:521-525.

    Strauss MB, Bryant BJ, Hart GB. Transcutaneous oxygen measurements under hyperbaric oxygen conditions as a predictor for healing of problem wounds. Foot Ankle Int 2002;23:933-937.

    Centers for Medicare & Medicaid Services. Coverage of hyperbaric oxygen (HBO) therapy for the treatment of diabetic wounds of the lower extremities. Transmittal AB-02-183. December 27, 2002. (Accessed September 24, 2004, at http://cms.hhs.gov/manuals/pm_trans/AB02183.pdf.)

    The authors reply: Dr. Chang raises the question of the importance of glycemic control in the prevention of progression of neuropathy and in the management of foot wounds. In a recent technical review on neuropathy for the American Diabetes Association (ADA),1 we did indeed emphasize the importance of achieving near-normal blood glucose levels in the prevention of neuropathy and in an attempt to slow progression. However, in our article, we aimed to provide guidelines on management based on properly designed trials. Although previous review articles and the ADA recommendations on glycemic control referred to by Chang represent conventional wisdom, there is a lack of evidence (from randomized, controlled trials) that the achievement of near-normal blood glucose levels can improve nerve function in patients with moderate-to-severe diabetic neuropathy who are at significant risk for ulceration. Thus, whereas there is clear evidence that glucose control is useful in preventing the progression of early neuropathy,2 data on the role of blood glucose control in the management of foot ulceration are conflicting.

    Dr. Aksenov questions our failure to support the role of hyperbaric oxygen in the treatment of diabetic wounds. Although some data support the use of hyperbaric oxygen in patients with ischemic foot ulcers that are not amenable to either bypass surgery or angioplasty, there is a lack of evidence to support its use in the management of neuropathic nonischemic foot ulcers, the topic of this article. The fact that the Center for Medicare and Medicaid Services, as well as other insurance carriers, recognizes the use of hyperbaric oxygen as an approved reimbursable treatment for problematic diabetic foot wounds cannot be regarded as confirmation of efficacy. At present, the role of hyperbaric oxygen in the management of purely neuropathic foot ulceration remains unsubstantiated.

    Andrew J.M. Boulton, M.D.

    University of Manchester

    Manchester M13 9WL, United Kingdom

    aboulton@med.miami.edu

    Robert S. Kirsner, M.D.

    University of Miami

    Miami, FL 33101

    Loretta Vileikyte, M.D.

    University of Manchester

    Manchester M13 9WL, United Kingdom

    References

    Boulton AJM, Malik RA, Arezzo JC, Sosenko JM. Diabetic somatic neuropathies. Diabetes Care 2004;27:1458-1486.

    The Diabetes Control and Complications Trial Research Group. The effect of intensive diabetes therapy on the development and progression of neuropathy. Ann Intern Med 1995;122:561-568.