SLR - July 2011 - Gian Steinhauser
Reference: Reiber, G, Smith D, Wallace C. (2002) Effect of Therapeutic Footwear on Foot Reulceration in Patients with Diabetes. A Randomized Control Trial. Journal of the American Medical Association, 287(19): 2552-2558
Scientific Literature Review
Reviewed By: Gian Steinhauser, DPM
Residency Program: Roxborough Memorial Hospital
Podiatric Relevance:
Diabetic patients with a history of ulceration are at high risk for reulceration and are commonly prescribed therapeutic footwear in the hopes of preventing future complications.
Methods:
A randomized clinical trial was conducted of 400 diabetic patients with a history of foot ulcer in Washington State health care organizations who did not require custom shoes for foot deformities were enrolled between August of 1997 and 1998 and followed for 2 years. Data was collected at regular intervals, including physical, foot and diabetes characteristics, footwear use, foot lesions and ulcers.
Study eligibility criteria were: diagnosed diabetes; age 45 to 84 years; history of a full-thickness foot lesion or foot infection requiring antibiotic treatment; no foot deformities requiring a custom shoe; ability to walk 1 block and climb 1 flight of stairs per day.
Exclusion criteria were: prior lower-extremity amputation of more than 1 digit; presence of either unhealed or healed lesion in the prior month; requirement of boots, custom shoes, or nontraditional footwear for daily activities; nonambulatory status; or terminal illness that would make 2-year survival unlikely,
One hundred twenty-one men and women were randomly assigned to receive 3 pairs of therapeutic shoes and 3 pairs of customized medium-density cork inserts with a neoprene closed-cell cover; 119 were randomly assigned to receive 3 pairs of therapeutic shoes and 3 pairs of prefabricated, tapered polyurethane inserts with a brushed nylon cover; and 160 were randomly assigned as controls to wear their usual footwear.
Results:
Two-year cumulative reulceration incidence across the 3 groups was low: 15% in the cork-insert group, 14% in the prefabricated-insert group, and 17% in controls. There were no statistically significant differences in ulcers or ulcer episodes between groups. The risk ratio (RR) for persons with 1 or more reulcerations in the group with therapeutic shoes and cork inserts compared with those in the control group was 0.88 (95% CI, 0.51-1.52). The RR comparing the group with prefabricated inserts with the control group was 0.85 (95% CI, 0.48-1.48). When examining total ulcer episodes, the RR comparing the group with cork inserts with controls was 0.86 (95% CI, 0.45-1.63) and the RR comparing the group with prefabricated inserts with controls was 0.80 (95% CI, 0.41-1.56).
The 2 pivotal events that contributed most to ulcer episodes were shoes (39%; 10.7% due to intervention shoes and 28.6% due to nonintervention shoes) and external trauma (31%). Among the 9 persons who developed ulcers while wearing intervention shoes, all had foot insensitivity. Among the 24 persons who developed ulcers while not wearing intervention shoes, 88% had foot insensitivity, and among the 26 patients whose pivotal event was external trauma, 96% had foot insensitivity.
Conclusions:
This study of persons without severe foot deformity does not provide evidence to support widespread dispensing of therapeutic shoes and inserts to diabetic patients with a history of foot ulcer. Study shoes and custom cork or preformed polyurethane inserts conferred no significant ulcer reduction compared with control footwear. This study suggests that careful attention to foot care by health care professionals may be more important than therapeutic footwear but does not negate the possibility that special footwear is beneficial in persons with diabetes who do not receive such close attention to foot care by their health care providers or in individuals with severe foot deformities.