Correspondence

Foot Disease in Diabetes

N Engl J Med 1995; 332:269-270January 26, 1995

Article

To the Editor:

In discussing the care of neuropathic ulcers, Caputo et al. (Sept. 29 issue)1 claim that “topical iodine preparations, astringents, and hydrogen peroxide interfere with the healing of the wound,” and they cite two references to support this statement.2,3 The first reference reported not that these topical agents interfered with wound healing but rather that povidone–iodine and saline were less effective than silver sulfadiazine in reducing bacterial counts in chronic pressure ulcers.2 Many other studies have documented the broad antimicrobial effectiveness of povidone–iodine. A controlled clinical study that we sponsored showed that wounds treated with povidone–iodine cream had 100 percent reepithelialization in a significantly shorter period (12.1 days, P<0.01) than wounds treated with silver sulfadiazine cream (16.1 days) or left untreated (15.2 days).4 Several other controlled clinical studies have shown wound healing to be enhanced, rather than harmed, by treatment with povidone–iodine cream.5

The second cited reference reported the inhibition of cultured human fibroblasts by topical antiseptics, including 1 percent povidone–iodine solution,3 which is of questionable clinical relevance. Most controlled clinical studies have shown that the povidone–iodine moiety (without detergents) does not interfere with overall wound healing or harm delicate tissues. The Food and Drug Administration has evaluated the data on povidone–iodine and recently concluded that it does not delay wound healing in humans.6

Paul D. Goldenheim, M.D.
Purdue Frederick Company, Norwalk, CT 06856

6 References

1. 1

   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
   Full Text | Web of Science | Medline

2. 2

   Kucan JO, Robson MC, Heggers JP, Ko F. Comparison of silver sulfadiazine, povidone-iodine and physiologic saline in the treatment of chronic pressure ulcers. J Am Geriatr Soc 1981;29:232-235
   Web of Science | Medline

3. 3

   Lineaweaver W, Howard R, Soucy D, et al. Topical antimicrobial toxicity. Arch Surg 1985;120:267-270
   Web of Science | Medline

4. 4

   Hopf K, Grandy R, Stahl-Bayliss C, Fitzmartin R. The effect of betadine cream vs. silvadene cream on re-epithelialization in uninfected experimental wounds. Wounds 1991;3:30-31
   

5. 5

   Mayer DA, Tsapogas MJ. Povidone-iodine and wound healing: a critical review. Wounds 1993;5:14-23
   

6. 6

   Food and Drug Administration. Oral health care drug products for over-the-counter human use: tentative final monograph for oral antiseptic drug products. Fed Regist 1994;59:6099-6099
   

To the Editor:

Caputo et al. describe both the steps to identify and provide preventive care for patients at high risk for foot disease and the medical and surgical aspects of limb salvage. In the discussion of the test for sensation with a 5:07 nylon monofilament, they might have cited the prospective data on the outcomes for diabetic patients who feel the monofilament, as compared with the outcomes for those who do not. The odds of ulceration were 9.9 times higher (95 percent confidence interval, 4.8 to 21.0) and the odds of amputation were 17 times higher (95 percent confidence interval, 4.5 to 95.0) for the patients without sensation.1 The simple monofilament sensory examination allows patients to recognize the actual loss of sensation in the foot as compared with the hand.

In the Indian Health Service, we have attempted to identify diabetic patients at high risk for ulceration so we can provide them with intensive preventive services. Table 1Table 1Criteria for Predicting Plantar Ulceration in Diabetic Patients. summarizes the sensitivity and specificity of selected criteria for a high risk of ulceration in a cohort of diabetic patients observed for a mean of 28 months. At least one ulcer developed in 41 of the 358 patients who were examined. The ankle brachial index was also measured in a subgroup of 307 patients, 35 of whom had at least one ulcer.

We need to prevent the ulcerations that lead to surgery and amputation in diabetic patients.

Dorothy Gohdes, M.D.
Indian Health Service, Albuquerque, NM 87110

Stephen Rith-Najarian, M.D.
Indian Health Service, Bemidji, MN 56601

1 References

1. 1

   Rith-Najarian SJ, Stolusky T, Gohdes DM. Identifying diabetic patients at high risk for lower-extremity amputation in a primary health care setting: a prospective evaluation of simple screening criteria. Diabetes Care 1992;15:1386-1389
   CrossRef | Web of Science | Medline

To the Editor:

We agree with Caputo et al. that topical hyperbaric-oxygen therapy in the treatment of postoperative diabetic foot ulcers is not beneficial. The administration of oxygen topically would not be expected to increase oxygen saturation of hemoglobin and plasma as is seen with hyperbaric-oxygen treatments in monoplace or multiplace chambers. The Undersea and Hyperbaric Medical Society defines hyperbaric-oxygen therapy as systemic administration of 100 percent oxygen under a pressure greater than 1 atmosphere.1

Hyperbaric-oxygen therapy has been shown to enhance the treatment of diabetic foot ulcers2 and can consistently be of benefit for selected patients. For diabetic patients who have grade II, III, or IV foot ulcers according to the Wagner classification,3 with Doppler ankle perfusion pressures of more than 75 mm Hg in the affected foot and transcutaneous oxygen tension of more than 35 mm Hg in the area adjacent to the wound, hyperbaric oxygen is appropriate to consider as adjunctive therapy.4

M. Capelli-Schellpfeffer, M.D.
Louis H. Philipson, M.D., Ph.D.
University of Chicago, Chicago, IL 60637

4 References

1. 1

   Committee on Hyperbaric Oxygenation of the Undersea and Hyperbaric Medical Society. Report on hyperbaric oxygen therapy. Bethesda, Md.: Undersea and Hyperbaric Medical Society, 1986.
   

2. 2

   Baroni G, Porro T, Faglia E, et al. Hyperbaric oxygen in diabetic gangrene treatment. Diabetes Care 1987;10:81-86
   CrossRef | Web of Science | Medline

3. 3

   Wagner FW Jr. The dysvascular foot: a system for diagnosis and treatment. Foot Ankle 1981;2:64-122
   Medline

4. 4

   Kindwall EP, Goldman RW. Hyperbaric medicine procedures. Milwaukee: Medical College of Wisconsin, 1988:116-20.
   

Author/Editor Response

The authors reply:

To the Editor: We appreciate the comments of Drs. Gohdes and Rith-Najarian, which underscore our emphasis on the prevention of neuropathic foot ulceration and amputation. Their data provide additional support for yearly monofilament screening of all diabetic patients.

There are no well-designed studies that support the use of topical hyperbaric oxygen in the routine management of foot infections in patients with diabetes, and most authorities do not support its use. Drs. Capelli-Schellpfeffer and Philipson suggest that immersion hyperbaric-oxygen therapy is beneficial, but their suggestion is based on a nonrandomized study in which 18 of 28 patients received hyperbaric-oxygen treatment (90 minutes per day) for a mean (±SD) of 34.0±21.8 days.1 These daily treatments are expensive, and treatment is limited to centers with immersion chambers. In view of the lack of carefully designed studies showing a cost-effective benefit,2 support for this treatment is questionable.

Limitations on the length of our article prevented a full discussion of some controversies, including that which surrounds the use of topical antiseptics and wound healing. We sought to leave the reader with a sense of caution regarding the use of any topical preparation, since the studies to date are inconclusive. For example, according to the review of povidone–iodine by Mayer and Tsapongas, several studies showed no effect, a few showed a benefit, and some showed that wound healing was impaired.3 Dr. Goldenheim cites a study supported by his company, which was published only in abstract form.4 Critical data on wound management (e.g., the type of dressing) and a detailed analysis of healing with the control preparation are not given, which leaves the conclusions open to question.

Concentrations of topical antiseptics that are dilute enough to be safe may be too dilute to provide antibacterial activity. The use of topical antiseptics in the management of neuropathic plantar ulcers in patients with diabetes remains unsupported by well-designed trials.

Gregory M. Caputo, M.D.
Jan S. Ulbrecht, M.D.
Milton S. Hershey Medical Center, Hershey, PA 17033

Gary W. Gibbons, M.D.
New England Deaconess Hospital, Boston, MA 02215

4 References

1. 1

   Baroni G, Porro T, Faglia E, et al. Hyperbaric oxygen in diabetic gangrene treatment. Diabetes Care 1987;10:81-86
   CrossRef | Web of Science | Medline

2. 2

   Gibbons GW, Marcaccio EJ Jr, Burgess AM, et al. Improved quality of diabetic foot care, 1984 vs 1990: reduced length of stay and costs, insufficient reimbursement. Arch Surg 1993;128:576-581
   Web of Science | Medline

3. 3

   Mayer DA, Tsapongas MJ. Povidone-iodine and wound healing: a critical review. Wounds 1993;5:14-23
   

4. 4

   Hopf K, Grandy R, Stahly-Bayliss C, Fitzmartin R. The effect of betadine cream vs. silvadene cream on re-epithelialization in uninfected experimental wounds. Wounds 1991;3:30-31
   

Citing Articles (1)

Citing Articles

1. 1

   Marek Smieja, Dereck L. Hunt, David Edelman, Edward Etchells, Jacques Cornuz, David L. Simel, for the International Cooperative G. (1999) Clinical Examination for the Detection of Protective Sensation in the Feet of Diabetic Patients. Journal of General Internal Medicine 14:7, 418-424
   CrossRef