Sunday, February 27, 2005

New research should have impact on clinical practice

The latest Diabetes Care has two important papers:
Evaluation of Removable and Irremovable Cast Walkers in the Healing of Diabetic Foot Wounds A randomized controlled trial
David G. Armstrong, Lawrence A. Lavery, Stephanie Wu, Andrew J.M. Boulton

OBJECTIVE—The purpose of this study was to evaluate the effectiveness of a removable cast walker (RCW) and an "instant" total contact cast (iTCC) in healing neuropathic diabetic foot ulcerations.
RESEARCH DESIGN AND METHODS—We randomly assigned 50 patients with University of Texas grade 1A diabetic foot ulcerations into one of two off-loading treatment groups: an RCW or the same RCW wrapped with a cohesive bandage (iTCC) so patients could not easily remove the device. Subjects were evaluated weekly for 12 weeks or until wound healing.
RESULTS—An intent-to-treat analysis showed that a higher proportion of patients had ulcers that were healed at 12 weeks in the iTCC group than in the RCW group (82.6 vs. 51.9%, P = 0.02, odds ratio 1.8 [95% CI 1.1–2.9]). Of the patients with ulcers that healed, those treated with an iTCC healed significantly sooner (41.6 ± 18.7 vs. 58.0 ± 15.2 days, P = 0.02). CONCLUSIONS—Modification of a standard RCW to increase patient adherence to pressure off-loading may increase both the proportion of ulcers that heal and the rate of healing of diabetic neuropathic wounds.

A Randomized Trial of Two Irremovable Off-Loading Devices in the Management of Plantar Neuropathic Diabetic Foot Ulcers
Ira A. Katz, Anthony Harlan, Bresta Miranda-Palma, Luz Prieto-Sanchez, David G. Armstrong, John H. Bowker, Mark S. Mizel, Andrew J.M. Boulton

OBJECTIVE—The purpose of this study was to compare the effectiveness of a removable cast walker (RCW) rendered irremovable (iTCC) with the total contact cast (TCC) in the treatment of diabetic neuropathic plantar foot ulcers.
RESEARCH DESIGN AND METHODS—In a prospective, randomized, controlled trial, 41 consecutive diabetic patients with chronic, nonischemic, neuropathic plantar foot ulcers were randomly assigned to one of two groups: a RCW rendered irremovable by wrapping it with a single layer of fiberglass casting material (i.e., an iTCC) or a standard TCC. Primary outcome measures were the proportion of patients with ulcers that healed at 12 weeks, healing rates, complication rates, cast placement/removal times, and costs.
RESULTS—The proportions of patients with ulcers that healed within 12 weeks in the iTCC and TCC groups were 80 and 74%, respectively (94 and 93%, respectively, when patients who were lost to follow-up were excluded). Survival analysis (healing rates) was statistically equivalent in the two groups, as were complication rates, but with a trend toward benefit in the iTCC group. The iTCC took significantly less time to place and remove than the TCC with 39% and 36% reductions, respectively. There was also an overall lower cost associated with the use of the iTCC compared with the TCC.
CONCLUSIONS—The iTCC may be equally efficacious, faster to place, easier to use, and less expensive than the TCC in the treatment of diabetic plantar neuropathic foot ulcers

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