***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE To evaluate the efficacy of manufactured shoes specially design ed for diabetic patients ( Podiabetes by Buratto Italy ) to prevent relapses of foot ulcerations . RESEARCH DESIGN AND METHODS A prospect i ve multicenter r and omized follow-up study of patients with previous foot ulcerations was conducted . Patients were alternatively assigned to wear either their own shoes ( control group , C ; n = 36 ) or therapeutic shoes ( Podiabetes group , P ; n = 33 ) . The number of ulcer relapses was recorded during 1-year follow-up . RESULTS Both C and P groups had similar risk factors for foot ulceration ( i.e. , previous foot ulceration , mean vibratory perception threshold > 25 mV ) . After 1 year , the foot ulcer relapses were significantly lower in P than in C ( 27.7 vs. 58.3 % ; P = 0.009 ; odds ratio 0.26 [ 0.2–1.54 ] ) . In a multiple regression analysis , the use of therapeutic shoes was negatively associated with foot ulcer relapses ( coefficient of variation = −0.315 ; 95 % confidence interval = −0.54 to −0.08 ; P = 0.009 ) . CONCLUSIONS The use of specially design ed shoes is effective in preventing relapses in diabetic patients with previous ulceration 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 prospect i ve , r and omized , controlled trial , 41 consecutive diabetic patients with chronic , nonischemic , neuropathic plantar foot ulcers were r and omly 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 st and ard 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 Neuropathic  plantar ulcers  are classical lesions secondary to diabetic polyneuropathy ( 1,2 ) . The worldwide gold st and ard treatment is the nonremovable off-loading cast ( 3–5 ) . However , the device is not widely used due to concerns related to risk factors of the off-loading cast ( i.e. , joint rigidity , additional ulcer formation beneath the cast , and infection of the ulcer enclosed in the cast ) . Our group recently demonstrated that it is possible to reduce the risk of side effects reported in literature by constructing the off-loading cast using fiberglass b and ages of different rigidity . Considering the device ’s scarce application because of the side effects , we conducted a controlled , r and omized , prospect i ve trial to evaluate the safety and efficacy of a removable pneumatic cast walker in comparison with a nonremovable fiberglass off-loading cast .  Between January 2005 and October 2005 , 60 consecutive diabetic patients with neuropathic plantar ulcers were seen and r and omly assigned to two groups : group A , using an Aircast Pneumatic Walker ( XP Diabetic Walker ) ; and group B , using the fiberglass off-loading cast .  All participants had peripheral neuropathy , as highlighted by insensitivity to 10 g monofilament and vibration perception threshold measured by biothesiometer at malleolus of at least 25 volts , and presented OBJECTIVE —This study was design ed to test the safety , effectiveness , and costs of off-loading with a novel , off-the-shelf irremovable device in the management of diabetic foot ulceration ( DFU ) . RESEARCH DESIGN AND METHODS —We prospect ively evaluated off-loading of neuropathic plantar ulcers in 40 diabetic out patients attending our diabetic foot clinic and compared healing rates at the 12-week follow-up , number and severity of adverse events , healing time , costs and applicability of the device , and patients ’ satisfaction between those r and omly assigned to total contact casting ( TCC ; group A ) or to the Optima Diab walker ( group B ) . Deep or infected ulcers were excluded . RESULTS —No difference between groups A and B was observed in healing rates at 12 weeks ( 95 vs. 85 % ) , healing time ( 6.5 ± 4.4 vs. 6.7 ± 3.4 weeks ) , and number of adverse events ( six versus four ) . Treatment was significantly less expensive in group B , which showed a mean reduction of costs of 78 % compared with group A ( P < 0.001 ) . Practicability was more favorable in group B , with a reduction of 77 and 58 % of the time required for application and removal of the devices , respectively ( P < 0.001 ) . Patients ’ satisfaction with the treatment was higher in group B ( P < 0.01 ) . CONCLUSIONS —The Optima Diab walker is as safe and effective as TCC in the management of DFU , but its lower costs and better applicability may be of help in spreading the practice of off-loading among the centers that manage the diabetic foot OBJECTIVE To compare the efficacy , safety , and compliance of a nonremovable fiberglass cast boot and off-loading shoes in the treatment of  diabetic plantar ulcers .  RESEARCH DESIGN AND METHODS Patients ( n = 93 ) with noninfected , nonischemic plantar ulcers were included in this prospect i ve nonr and omized study . Treatment used a nonremovable fiberglass cast boot for longer st and ing and deeper ulcers ( n = 42 ) and a half shoe or heel-relief shoe for other ulcers ( n = 51 ) . We evaluated off-loading therapy , compliance , and complications in both groups . RESULTS The healing rate was significantly higher with the cast boot than with the off-loading shoe ( 81 vs. 70 % , P = 0.017 ) , with healing times of 68.6 + /- 35.1 vs. 134.2 + /- 133.0 days , respectively , and hazard ratio 1.68 ( 95 % CI 1.04 - 2.70 ) ; complete compliance with treatment was 98 vs. 10 % ( P = 0.001 ) , respectively . Secondary osteomyelitis developed in 3 patients in the cast boot group and 13 patients in the off-loading shoe group ( P = 0.026 ) . CONCLUSIONS A nonremovable fiberglass cast boot was effective in healing diabetic plantar ulcers and in decreasing the risk of secondary osteomyelitis . The cast boot forced compliance with off-loading , thus promoting healing OBJECTIVE To evaluate the efficacy of a removable cast walker compared with that of a nonremovable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer . RESEARCH DESIGN AND METHODS Forty-five adult diabetic patients with nonischemic , noninfected neuropathic plantar ulcer were r and omly assigned for treatment with a nonremovable fiberglass off-bearing cast ( total contact cast [ TCC ] group ) or walker cast ( Stabil-D group ) . Treatment duration was 90 days . Percent reduction in ulcer surface area and total healing rates were evaluated after treatment . RESULTS A total of 48 patients were screened ; however , 2 patients in the TCC group and 1 patient in the Stabil-D group did not complete the study and were considered dropouts . There were no significant differences in demographic and clinic characteristics of the 45 patients completing the study .  Ulcer surface decreased from 1.41 to 0.21 cm2 ( P < 0.001 ) in the TCC group and from 2.18 to 0.45 cm2 ( P < 0.001 ) in the Stabil-D group , with no significant differences between groups ( P = 0.722 ) . Seventeen patients ( 73.9 % ) in the TCC group and 16 patients ( 72.7 % ) in the Stabil-D group achieved healing ( P = 0.794 ) . Average healing time was 35.3 ± 3.1 and 39.7 ± 4.2 days in the TCC and Stabil-D group , respectively ( P = 0.708 ) . CONCLUSIONS The Stabil-D cast walker , although removable , was equivalent in efficacy to the TCC in terms of ulcer size reduction and total healing rate . The easier use of Stabil-D may help increase the use of off-loading devices in the management of plantar neuropathic diabetic foot ulcers The objective of this study was to compare the effectiveness of irremovable total-contact casts ( TCC ) and custom-made temporary footwear ( CTF ) to heal  neuropathic foot ulcerations in individuals with diabetes . In this prospect i ve clinical trial , 43 patients with plantar ulcer Grade 1 or 2 ( Wagner scale ) were r and omized to one of two off-loading modalities : TCC or CTF . Outcomes assessed were wound surface area reduction ( cm2 ) and time to wound healing ( days ) at 2 , 4 , 8 and 16 weeks . To evaluate safety , possible side effects were recorded at each follow-up visit . The results showed no significant difference in wound surface area reduction ( adjusted for baseline wound surface ) at 2 , 4 , 8 or 16 weeks ( adjusted mean difference 0.10 cm2 ; 95 % CI −0.92−0.72 at 16 weeks ) . At 16 weeks , 12 patients had a completely healed ulcer , 6 per group . The median time to healing was shorter for the patients using a cast ( 52 vs. 90 days , p = 0.26 ) . Five patients with TCC and two with CTF developed device-related complications . It was concluded that : ( i ) the rate of wound healing is not significantly different for patients treated with CTF or TCC . The difference in wound surface area was small and not significant at any time during follow-up ; and ( ii ) the difference in healing time ( 38 days ) may have attained statistical significance if the numbers in these sub-groups ( 2 × 6 ) had been higher . Since there appears to be little difference in effectiveness between both off-loading modalities , further investigation into the benefits of CTF is warranted CONTEXT Many people with diabetes experience lower-limb ulcers . Footwear has been implicated as a primary cause of foot ulcers , yet research is limited on the efficacy of shoe and insert combinations to prevent reulceration . OBJECTIVE To determine whether extra-depth and -width therapeutic shoes used with 2 types of inserts reduce reulceration in diabetic individuals with a history of foot ulcer . DESIGN , SETTING , AND PARTICIPANTS R and omized clinical trial of 400 diabetes patients with history of foot ulcer in 2 Washington State health care organizations who did not require custom shoes for foot deformity and were enrolled between August 1997 and December 1998 and followed up for 2 years . Data collected at regular intervals documented physical , foot , and diabetes characteristics ; footwear use ; foot lesions ; and ulcers . INTERVENTIONS Participants were r and omly assigned to receive 3 pairs of therapeutic shoes and 3 pairs of customized medium-density cork inserts with a neoprene closed-cell cover ( n = 121 ) ; to receive 3 pairs of therapeutic shoes and 3 pairs of prefabricated , tapered polyurethane inserts with a brushed nylon cover ( n = 119 ) ; or to wear their usual footwear ( controls ; n = 160 ) . MAIN OUTCOME MEASURE Foot reulceration , compared among the 3 groups . 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 . In the intent-to-treat analysis , patients assigned to therapeutic shoes did not have a significantly lower risk of reulceration compared with controls ( risk ratio [ RR ] for the cork-insert group , 0.88 ; 95 % confidence interval [ CI ] , 0.51 - 1.52 and RR the for prefabricated-insert group , 0.85 ; 95 % CI , 0.48 - 1.48 ) . All ulcer episodes in patients assigned to therapeutic shoes and 88 % wearing non study shoes occurred in patients with 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 con 
    Output:
    
This analysis demonstrated improved wound healing with total contact casting over removable cast walker , therapeutic shoes , and conventional therapy .
There was no advantage of irremovable cast walkers over total contact casting .
There was improved healing with half-shoe compared with conventional wound care .
Therapeutic shoes and insoles reduced relapse rate in comparison with regular footwear .
Data were sparse regarding other off-loading methods .
Although based on low- quality evidence ( ie , evidence warranting lower certainty ) , benefits are demonstrated for use of total contact casting and irremovable cast walkers in the treatment of diabetic foot ulcers .
Reduced relapse rate is demonstrated with various therapeutic shoes and insoles in comparison with regular footwear