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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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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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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Sunday, February 06, 2005
RCT on Foot orthoses and low back pain
A Controlled Randomized Study of the Effect of Training With Orthoses on the Incidence of Weight Bearing Induced Back Pain Among Infantry Recruits. Spine. 2005 Feb 1;30(3):272-275.Milgrom C, Finestone A, Lubovsky O, Zin D, Lahad A.
Quote:
STUDY DESIGN.: Randomized controlled trial. OBJECTIVES.: To determine if the use of custom shoe orthoses can lessen the incidence of weight bearing-induced back pain. SUMMARY OF BACKGROUND DATA.: The scientific basis for the use of orthoses to prevent back pain is based principally on studies that show that shoe orthoses can attenuate the shock wave generated at heel strike. The repetitive impulsive loading that occurs because of this shock wave can cause wear of the mechanical structures of the back. Previous randomized studies showed mixed results in preventing back pain, were not blinded, and used orthoses for only short periods of time. METHODS.: A total of 404 eligible new infantry recruits without a history of prior back pain were randomly assigned to received either custom soft, semirigid biomechanical, or simple shoe inserts without supportive or shock absorbing qualities. Recruits were reviewed biweekly by an orthopaedist for back signs and symptoms during the course of 14 weeks of basic training RESULTS.: The overall incidence of back pain was 14%. By intention-to treat and per-protocol analyses, there was no statistically significant difference between the incidence of either subjective or objective back pain among the 3 treatment groups. Significantly more recruits who received soft custom orthoses finished training in their assigned orthoses (67.5%) than those who received semirigid biomechanical orthoses (45.5%) or simple shoe inserts (48.6%), P = 0.001. CONCLUSIONS.: The results of this study do not support the use of orthoses, either custom soft or semirigid biomechanical, as prophylactic treatment for weight bearing-induced back pain. Custom soft orthoses had a higher utilization rate than the semirigid biomechanical or simple shoe inserts. The pretraining physical fitness and sports participation of recruits were not related to the incidence of weight bearing-induced back pain.
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Quote:
STUDY DESIGN.: Randomized controlled trial. OBJECTIVES.: To determine if the use of custom shoe orthoses can lessen the incidence of weight bearing-induced back pain. SUMMARY OF BACKGROUND DATA.: The scientific basis for the use of orthoses to prevent back pain is based principally on studies that show that shoe orthoses can attenuate the shock wave generated at heel strike. The repetitive impulsive loading that occurs because of this shock wave can cause wear of the mechanical structures of the back. Previous randomized studies showed mixed results in preventing back pain, were not blinded, and used orthoses for only short periods of time. METHODS.: A total of 404 eligible new infantry recruits without a history of prior back pain were randomly assigned to received either custom soft, semirigid biomechanical, or simple shoe inserts without supportive or shock absorbing qualities. Recruits were reviewed biweekly by an orthopaedist for back signs and symptoms during the course of 14 weeks of basic training RESULTS.: The overall incidence of back pain was 14%. By intention-to treat and per-protocol analyses, there was no statistically significant difference between the incidence of either subjective or objective back pain among the 3 treatment groups. Significantly more recruits who received soft custom orthoses finished training in their assigned orthoses (67.5%) than those who received semirigid biomechanical orthoses (45.5%) or simple shoe inserts (48.6%), P = 0.001. CONCLUSIONS.: The results of this study do not support the use of orthoses, either custom soft or semirigid biomechanical, as prophylactic treatment for weight bearing-induced back pain. Custom soft orthoses had a higher utilization rate than the semirigid biomechanical or simple shoe inserts. The pretraining physical fitness and sports participation of recruits were not related to the incidence of weight bearing-induced back pain.
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RCT on Foot orthoses and low back pain
A Controlled Randomized Study of the Effect of Training With Orthoses on the Incidence of Weight Bearing Induced Back Pain Among Infantry Recruits. Spine. 2005 Feb 1;30(3):272-275.Milgrom C, Finestone A, Lubovsky O, Zin D, Lahad A.
Quote:
STUDY DESIGN.: Randomized controlled trial. OBJECTIVES.: To determine if the use of custom shoe orthoses can lessen the incidence of weight bearing-induced back pain. SUMMARY OF BACKGROUND DATA.: The scientific basis for the use of orthoses to prevent back pain is based principally on studies that show that shoe orthoses can attenuate the shock wave generated at heel strike. The repetitive impulsive loading that occurs because of this shock wave can cause wear of the mechanical structures of the back. Previous randomized studies showed mixed results in preventing back pain, were not blinded, and used orthoses for only short periods of time. METHODS.: A total of 404 eligible new infantry recruits without a history of prior back pain were randomly assigned to received either custom soft, semirigid biomechanical, or simple shoe inserts without supportive or shock absorbing qualities. Recruits were reviewed biweekly by an orthopaedist for back signs and symptoms during the course of 14 weeks of basic training RESULTS.: The overall incidence of back pain was 14%. By intention-to treat and per-protocol analyses, there was no statistically significant difference between the incidence of either subjective or objective back pain among the 3 treatment groups. Significantly more recruits who received soft custom orthoses finished training in their assigned orthoses (67.5%) than those who received semirigid biomechanical orthoses (45.5%) or simple shoe inserts (48.6%), P = 0.001. CONCLUSIONS.: The results of this study do not support the use of orthoses, either custom soft or semirigid biomechanical, as prophylactic treatment for weight bearing-induced back pain. Custom soft orthoses had a higher utilization rate than the semirigid biomechanical or simple shoe inserts. The pretraining physical fitness and sports participation of recruits were not related to the incidence of weight bearing-induced back pain.
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Quote:
STUDY DESIGN.: Randomized controlled trial. OBJECTIVES.: To determine if the use of custom shoe orthoses can lessen the incidence of weight bearing-induced back pain. SUMMARY OF BACKGROUND DATA.: The scientific basis for the use of orthoses to prevent back pain is based principally on studies that show that shoe orthoses can attenuate the shock wave generated at heel strike. The repetitive impulsive loading that occurs because of this shock wave can cause wear of the mechanical structures of the back. Previous randomized studies showed mixed results in preventing back pain, were not blinded, and used orthoses for only short periods of time. METHODS.: A total of 404 eligible new infantry recruits without a history of prior back pain were randomly assigned to received either custom soft, semirigid biomechanical, or simple shoe inserts without supportive or shock absorbing qualities. Recruits were reviewed biweekly by an orthopaedist for back signs and symptoms during the course of 14 weeks of basic training RESULTS.: The overall incidence of back pain was 14%. By intention-to treat and per-protocol analyses, there was no statistically significant difference between the incidence of either subjective or objective back pain among the 3 treatment groups. Significantly more recruits who received soft custom orthoses finished training in their assigned orthoses (67.5%) than those who received semirigid biomechanical orthoses (45.5%) or simple shoe inserts (48.6%), P = 0.001. CONCLUSIONS.: The results of this study do not support the use of orthoses, either custom soft or semirigid biomechanical, as prophylactic treatment for weight bearing-induced back pain. Custom soft orthoses had a higher utilization rate than the semirigid biomechanical or simple shoe inserts. The pretraining physical fitness and sports participation of recruits were not related to the incidence of weight bearing-induced back pain.
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