Total contact casting for diabetic neuropathic ulcers.

Total contact casting (TCC) is an effective therapy for healing chronic neuropathic plantar ulcers in individuals with diabetes mellitus and other chronic sensory neuropathies.[1] The use of TCC in the clinical management of neuropathic wounds has gained considerable acceptance over the past 30 years, largely through the efforts of Dr Paul Brand and colleagues at the Gillis W Long National Hansen's Disease Center in Carville, La. Dr Brand has theorized that most plantar ulcers originate from repetitive trauma in the presence of insensitivity of the feet (ie, sensory neuropathy).[2] Total contact casts are snug-fitting, below-knee casts that protect insensitive limbs from repetitive trauma, promote ulcer healing, and allow the patient to remain ambulatory. A more thorough description of the application of TCC is presented elsewhere.[3]

Because only neuropathic wounds are appropriate for treatment with TCC or other pressure-relieving methods, this update will focus on the effectiveness of TCC for diabetic neuropathic plantar ulcers. In addition, some factors are discussed that have been reported to compromise TCC's clinical utility, such as the definition of ulcer healing, ulcer recidivism, complication rates, and autonomic nervous system dysfunction.

Indications and Contraindications of Total Contact Casting

Total contact casts are indicated for superficial plantar ulcers (ie, Wagner grades I and II) in the presence of decreased or absent sensation.[3] Wagner grade I and II ulcers are defined as ulcers that involve the epidermis, dermis, or other subcutaneous layers (deep fasciae, muscles, tendons, joints, or bones) but that are without evidence of infection.[4] Total contact casting is contraindicated in deep foot ulcers where abscess, osteomyelitis, or similar deep infection or gangrene is present (Wagner grade III, IV, or V).[3] These cases typically require immediate surgical attention or amputation.[4]

[Sinacore DR. Total contact casting for diabetic neuropathic ulcers. Phys Ther. 1996;76:296-301.] Key Words: Diabetes; Diabetic neuropathies; Lower extremity, ankle and foot; Orthotics/splints/casts, lower extremity; Ulcer. Total contact casts are thought to promote ulcer healing by reducing excessive plantar pressures. Excessive plantar pressures are reduced by increasing the weight-bearing surface area of the foot and leg.[2] Total contact casts also promote healing by immobilizing the foot and ankle, controlling edema, and protecting the foot from trauma.[2.3]

Studies Supporting the Use of Total Contact Casting

The effectiveness of TCC has been documented in several clinical reports.[1.5-16] A review of studies from 1983 to 1995 showed favorable results for the use of TCC in the management of Wagner grade I and II neuropathic ulcers (Table). Although the sample size in each study was small (range = 1-80 ulcers), in all the reports a total 389 neuropathic ulcers in an estimated 365 subjects with diabetes mellitus demonstrated complete healing 91% (range=73%-100%) of the time. In 3 of the 11 reports in which the sample consisted of more than one subject, 100% of the subjects had ulcers that healed in an average of 43 days (Table). Healing times have consistently been quite rapid, averaging 37 to 65 days from the initial date of casting. These healing times are notable considering that the average length of time ulcers were reported to be present prior to TCC was typically 9 months (275 days). These healing times do not differ markedly from those of individuals with ulcers not attributable to diabetes, peripheral vascular disease, or severe ischemic changes.[16]

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Few studies have directly compared the effectiveness of TCC with that of other methods. One randomized, controlled clinical trial[10] compared TCC with traditional methods of management that consisted of daily dressing changes and therapetitic footwear modifications (eg, molded insoles, custom-made shoes). This study demonstrated TCC was more rapid and more effective than traditional wound care methods.[10] In addition to promoting faster healing times, TCC was better than daily dressing changes at preventing subsequent hospitalizations for foot infections or partial foot amputations.[10]

A variety of management strategies, each having some degree of success, have been proposed for diabetic foot ulcers. The Figure depicts the average healing times and the percentages of ulcers healed with some other common methods of healing.[1,5-20] When compared with other methods of healing, TCC is not only the fastest method of healing (ie, shortest number of days to complete healing) but also the most effective method of healing (highest percentage healed) (Figure). Other methods of treatment appear to be viable management alternatives, although TCC appears to be the best ambulatory treatment for diabetic plantar ulcers on insensitive feet. More research that directly compares TCC with alternative treatment methods is needed.

Complications in Use of Total Contact Casting

Numerous studies have documented and described complications from TCC (Table). One study demonstrated that as many as 43% of the subjects with diabetes treated by TCC developed minor complications.5 The overall average rate for all types of complications is estimated to be 20% (Table). The most often reported and well-known complications are superficial abrasions and fungal infections.

Abrasions can be caused by excessive movement of the foot or leg inside a loosely fitting cast, by damage to (eg, breakdown of) the cast due to moisture or trauma, or by improper application of the cast. These complications can lead to severe abrasions in areas of bony prominences or surrounding any windows cut into the cast. Typically, abrasions around bony prominences occur in approximately 27% of the patients treated by TCC.[1,7] Most often, these abrasions heal readily and do not delay subsequent cast applications or ulcer healing.

Some patients treated by TCC develop local fungal infections, usually on the digits.[21] In a study by Mueller et al,[10] 15% of the subjects with diabetes treated with TCC developed digital fungal infections. Generally, those fungal infections can be treated easily with a topical antifungal cream and do not prevent further casting.

In persons with underlying (occult) osteomyelitis or deep tissue infection, a more serious complication of casting can occur. Early detection of osteomyelitis is difficult in some patients with plantar surface ulcers. Some reports[1,8,15] have documented cases in which TCC has been used in patients with undiagnosed osteomyelitis. As would be expected, the outcomes in these cases have not been good, often resulting in immediate hospital admissions for limb-threatening (or life-threatening) infections from cellulitis or sepsis.[12]

Although complications have been reported with TCC, the benefits appear to outweigh the complications. Most reports indicate that the majority of complications can be minimized with careful application and close patient follow-up at frequent interval over a casting period.[1,5,8] The skills required to learn the safe application of TCC, although tedious to master, appear to result in effective treatment.

Ulcer Recurrence

Fifteen percent of all people with diabetes will develop at least one foot ulcer during their lifetime.[22] The likelihood of developing more than a single foot ulcer over a number of years of having diabetes mellitus is uncertain, but it appears to be high. Diabetic foot complications account for approximately 20% of all hospital admissions of individuals with diabetes.[22] Most people with diabetes who are over the age of 65 years require at least one hospitalization per year for foot related-complications.[23]

A few longitudinal studies of recurrence rates of foot ulcers treated by a variety of methods indicate that the likelihood of reulceration within the first 6 months after initial healing is quite high, prompting some experts to consider healing successful only after 6 months of continuous skin closure.[24,25] Using this criterion, Apelqvist et al[24,25] reported ulcer recurrence rates of 34%, 61%, and 70% after 1, 3, and 5 years, respectively, during follow-up observation. Follow-up at 2 years after initial ulcer healing indicates that the reoccurrence rates vary between 20% and 35%.[26,27] The overall average recurrence rate following treatment with TCC is estimated to be 32% (Table). The recurrence rates for ulcers in subjects having sensory neuropathy with or without diabetes mellitus, appears to be similar.[28]

Most ulcers reoccur within the first 6 months following initial ulcer healing, typically within the 3 or 4 weeks after initial healing. Brand[2] points out that this is a particularly vulnerable period for reulceration because the newly healed ulcer is not fully mature and is not yet able to withstand the vertical and shear stresses placed on it. Brand[2] recommends extreme caution by limiting weight-bearing activities during this period to allow complete wound consolidation and connective tissue remodeling.[2]

Judging the outcome of TCC depends on the definition of healing. Sinacore and colleagues.[1,10] define wound healing as the complete closure of an ulcer, with skin intact (complete epithelialization) and without drainage or sinus formation. These authors calculated the time it takes (in days), from the time of initial casting, for the ulcer to completely heal. Some authors define wound healing as at least 6 months of continuous skin closure.[24,25] definition obscures the recidivism rates after initial healing as well as the risk of reulceration early after total contact cast removal. Two groups of investigators[26,27] have reported ulcer recurrence rates of 35% to 57% within the first month after TCC.

Failure to Heal Ulcers with Total Contact Casting

Failure to achieve complete ulcer healing with TCC has been reported in several studies. Laing et al[8] reported a failure rate of 22% in 36 patients with diabetes who were treated by TCC, whereas Helm and Walker[7] estimated that 27% of their subjects failed to achieve complete ulcer healing with TCC. Sinacore et all initially observed a failure rate of 18%. In a controlled follow-up study, Mueller et al[10] observed that 10% of the ulcers failed to heal. Many of the failures of wound healing were observed in patients who tried a therapeutic course of TCC, but who refused subsequent casts despite evidence of ulcer healing.[1] Distinguishing those patients for whom TCC was an appropriate form of therapy and may have healed their neuropathic ulcers from those patients who may have had underlying pathology (eg, advanced peripheral vascular disease) and for whom TCC may not be a suitable form of therapy is requisite. Some of the failures of wound healing using TCC were seen in subjects whose ulcers did not heal due to undiagnosed deep tissue infection (eg, osteomyelitis), whereas other failures of wound healing occurred in subjects who did not comply with recommended follow-up procedures such as limiting their extent of walking. Thorough descriptions of the reasons for failure to achieve healing should be reported to clarify who is or is not a good candidate for TCC.

Autonomic Neuropathy 

The presence and severity of peripheral autonomic neuropathy may be partly responsible for the wound-healing failures observed with TCC.[29] In general, the presence and increasing severity of peripheral autonomic neuropathy indicate a poor prognosis, being associated with higher morbidity and mortality.29 Future research should address the role peripheral autonomic (sympathetic) impairments may have in the generation and management of diabetic foot ulcers.

Cost-Effectiveness of Total Contact Casting

Total contact casting appears to be highly cost-effective for healing chronic neuropathic ulcers. In general, outpatient applications of total contact casts cost very little when compared with in-hospital stays including daily wound care by professional nursing staff. The actual direct costs for diabetic (neuropathic) foot ulcers in the United States are not known. Smith et al[23] performed a 2-year prospective study of 429 ambulatory patients with diabetes mellitus who were classified as being at high, medium, or low risk for hospitalization. These authors reported that 58% of the patients in the high-risk group averaged 1.47 hospitalizations per patient over the 2-year period and that this group .averaged 14.6 hospital days per patient compared with 8.6 hospital days for the medium-risk group and 5.3 hospital days for the low-risk group. Based on current costs at our medical center, I conservatively estimate the average hospital-room costs for an in-hospital stay of 5.3 days to be $2,252. These estimates are conservative in that they do not reflect the costs of diagnostic workups or procedures (eg, roentgenography, bone scans, vascular studies), medications (eg, antibiotics, topical agents), or physicians' services.

In contrast, I estimate the current outpatient costs of TCC over a typical 8-week duration of casting, including six to eight cast changes, to average $810 to $1,050. These costs are far less than the costs associated with one annual stay in the hospital. Total contact casting appears to be not only an extremely rapid and effective form of therapy but also an extremely cost-effective technique for healing chronic neuropathic ulcers and preventing subsequent amputation.

Total contact casting allows patients to remain ambulatory throughout the ulcer healing period. In addition to patients remaining ambulatory, quite often they are able to maintain their employment status, so no loss of wages (indirect medical costs) are incurred. Additionally, few additional costs for wound care supplies are necessary because TCC requires little participation by the patient or family members to perform daily wound care.

Summary

Despite its limited therapeutic use, several research reports indicate that TCC is currently the most rapid and effective technique for healing diabetic neuropathic ulcers. Skilled application and careful follow-up of the wound are necessary to avoid complications and minimize the risks for reulceration. As more clinicians adopt this form of therapy, the successful treatment of neuropathic ulcers using TCC should result in a lower incidence of infection, hospitalization, and lower-extremity amputation and should reduce the costs associated with hospitalization and lost income in patients with chronic sensory neuropathies.

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References

[1] Sinacore DR, Mueller Mi, Diamond JE, et al. Diabetic neuropathic ulcers treated by total contact casting: a clinical report. Phys Ther. 1987;67:1543-1549. [2] Brand PW. The insensitive foot (including leprosy). In: Jahass MH, ed. D orders of the Foot. Philadelphia, Pa: WB Saunders Co; 1982:1266-1286. [3] Sinacore DR, Mueller M,J. Total contact casting in the treatment of neuropathic ulcers. In: Levin ME, O'Neal, LW, Bowker JH, eds. The Diabetic Foot. 5th ed. St Louis, Mo: Mosby-Year Book Inc; 1993:285-304. [4] Wagner FW Jr. The insensitive foot. In: Kiene RH, Johnson KA, eds. American Academy of Orthopaedic Surgeons Symposium on the Foot and Ankle,. St Louis, Mo: CV Mosby Co; 1983:135-158. [5] Boulton AJM, Bowker JH, Gadia M, et al. Use of plaster casts in the management of diabetic neuropathic foot ulcers. Diabetes Care. 1986; 9:149-152. [6] Diamond JE, Sinacore DR, Mueller MJ. Molded double-rocker plaster shoe for healing a diabetic plantar ulcer: a case report. Phys Ther. 1987;67:1550-1552. [7] Helm PA, Walker SC. Total contact casting in diabetic patients with neuropathic foot ulcerations. Arch Phys Med Rehabil. 1984;65:691-693. [8] Laing PW, Cogley DJ, Klenerman L. Neuropathic foot ulceration treated by total contact casts. J Bone Joint Sut:g [Br]. 1992;74:133-136. [9] Myerson M, Papa J, Eaton K, Wilson K. The total contact cast for management of neuropathic plantar ulceration of the foot. J Bone Joint Surg [Am]. 1992;74:261-269. [10] Mueller MJ, Diamond JE, Sinacore DR, et al. Total contact casting in treatment of diabetic plantar ulcers: a controlled clinical trial. Diabetes Care. 1989;12:384-388. [11] Nawoczenski DA, Birke JA, Graham SL, Koziatek E. The neuropathic foot--a management scheme: a case report. Phys Ther. 1989;69:287-291. [12] Pollard JP, LeQuesne LP. Method of healing diabetic forefoot ulcers. BMJ. 1983;286:436-437. [13] Walker SC, Helm PA. Total contact casting and chronic diabetic neuropathic foot ulcerations: healing rates bY wound location. Arch Phys Med Rehabil. 1987;68:217-221. [14] Diamond JE, Mueller MJ, Delitto A. Effect of total contact cast immobilization of subtalar and talocrural joint motion in patients with diabetes mellitus. Phys Ther. 1993;73:310-315. [15] Baker RE. Total contact casting. J Am Podiatr Med Assoc. 1995;853: 172-176. [16] Birke JA, Novick A, Patout CA, Coleman WC. Healing rates of plantar ulcers in leprosy and diabetes. Lepr Rev. 1992;63:365-374. [17] Holstein P, Larsen K, Sager P. Decompression with the aid of insoles in the treatment of diabetic neuropathic ulcers. Acta Orthop Scand. 1976;47:463-468. [18] Griffiths GD, Wieman TJ. Meticulous attention to foot care improves the prognosis in diabetic ulceration of the foot. Surg Gynecol Obstet. 1992;174:49-51. [19] Wieman TJ, Griffiths GD, Polk HC. Management of diabetic mid-foot ulcers. Ann Surg. 1992;215:627-632. [20] Holloway G.A,, Steed DL, DeMarco MJ, et al. A randomized, controlled multicenter dose-response trial of activated-platelet supernatent, topical CT-102 in chronic, nonhealing diabetic wounds. Wounds. 1993;5:198-206. [21] Little, Jr, Kobavashi GS, Bailey TC. Infection of the diabetic foot. In: Levin ME, O'Neal LW, Bowker JH, eds. The Diabetic Foot. 5th ed. St Louis, Mo: Mosby-Year Book Inc; 1993:181-198. [22] Reiber GE. Epidemiology of the diabetic foot. In: Levin ME, O'Neal LW, Bowker JH, eds. The, Diabetic Foot. 5th ed. St Louis, Mo: Mosby-Year Book Inc; 1993:1-15. [23] Smith DM, Weinberger M, Katz BP. A controlled trial to increase office visits and reduce hospitalizations. J Gen Intern Med. 1987;2:232-238. [24] Apelqvist J, Castenfors J, Larsson J, et al. Wound classification is more important than site of ulceration in the outcome of diabetic foot ulcers. Diabet Med. 1989;6:526-530. [25] Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993;233:485-491. [26] Helm PA, Walker SC, Pullium GF. Recurrence of neuropathic ulceration following healing in a total contact cast. Arch Phys Med Rehabil. 1991;72:967-970. [27] Diamond JE, Mueller MJ, Delitto A. Follow-up of patients with diabetes and previously healed plantar ulcers. Phys Ther. 1991; 71 (suppl):596. Abstract. [28] Soderberg GL. Follow-up of application of plaster-of-paris casts for non-infected plantar ulcers in field conditions. Lepr Rev. 1970;41:184-190. [29] Sinacore DR, Mueller MJ. Total contact casting for wound management. In: Gogia PP, ed. Clinical Wound Management. Thorofare, NJ: Slack Inc; 1995:147-162.

DR Sinacore, PhD, PT, is Assistant Professor, Program in Physical Therapy, Washington University School of Medicine, 660 S Euclid Ave, St. Louis, MO 63110 (USA) ([e-mail]), and Consultant Physical Therapist, Barnes-Jewish Hospital, Diabetic Foot Center, St Louis, MO 63110. Address all