***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 
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    Input: BACKGROUND  Infected foot wounds in patients with diabetes are the most common reason for diabetes-related hospital admission in the United States . Nonhealing foot wounds are the major precipitant of lower-extremity amputation in the diabetic population . HYPOTHESIS The null hypothesis was that there would be no difference in proportion of healing with or without use of a foot-level mechanical compression device . DESIGN Twelve-week , double-blind , r and omized , controlled trial . SETTING A university teaching hospital and related clinics . PATIENTS One hundred fifteen patients with diabetes , 74 % male , with foot infections requiring incision and debridement . INTERVENTION All patients received either a functioning or placebo ( nonfunctioning ) foot compression device ( Kinetic Concepts Inc , San Antonio , Tex ) . Patients and investigators were blinded to the functionality of the device . PRIMARY OUTCOME MEASURE Proportion of wound healing in each group . RESULTS There was a significantly higher proportion of healing in the active group than in the placebo group ( 39 [ 75 % ] of 52 patients vs 23 [ 51 % ] of 45 ; chi(2 ) = 6.0 ; P<.02 ; odds ratio , 2.9 ; 95 % confidence interval , 1 . 2 - 6.8 ) . In the placebo group , there was no difference in proportion of healing between those identified as compliant ( > /=50 hours of use per week ) vs noncompliant ( P = .10 ) . In patients receiving active units , more patients in the compliant subgroup experienced wound healing ( P<.03 ) . When compared as a whole , there was a significant trend toward an increasing proportion of healing from the placebo-noncompliant to the placebo-compliant to the active-noncompliant to the active-compliant groups ( chi(2)(trend ) = 8.3 ; P<.005 ) . CONCLUSIONS Edema reduction achieved in this study by way of a pump and wrap system may increase the proportion of wound healing in patients after debridement of foot infections in patients with diabetes . Furthermore , the data suggest a potential association between increased compliance with use of the device and an increased trend toward wound healing . Arch Surg . 2000;135:1405 - OBJECTIVE  Chronic diabetic foot ulcers  are a source of major concern for both patients and health care systems . The aim of this study was to evaluate the effect of hyperbaric oxygen therapy ( HBOT ) in the management of  chronic diabetic foot ulcers .  RESEARCH DESIGN AND METHODS The Hyperbaric Oxygen Therapy in Diabetics with Chronic Foot Ulcers ( HODFU ) study was a r and omized , single-center , double-blinded , placebo-controlled clinical trial . The outcomes for the group receiving HBOT were compared with those of the group receiving treatment with hyperbaric air . Treatments were given in a multi-place hyperbaric chamber for 85-min daily ( session duration 95 min ) , five days a week for eight weeks ( 40 treatment sessions ) . The study was performed in an ambulatory setting . RESULTS Ninety-four patients with Wagner grade 2 , 3 , or 4 ulcers , which had been present for > 3 months , were studied . In the intention-to-treat analysis , complete healing of the index ulcer was achieved in 37 patients at 1-year of follow-up : 25/48 ( 52 % ) in the HBOT group and 12/42 ( 29 % ) in the placebo group ( P = 0.03 ) . In a sub- analysis of those patients completing > 35 HBOT sessions , healing of the index ulcer occurred in 23/38 ( 61 % ) in the HBOT group and 10/37 ( 27 % ) in the placebo group ( P = 0.009 ) . The frequency of adverse events was low . CONCLUSIONS The HODFU study showed that adjunctive treatment with HBOT facilitates healing of chronic foot ulcers in selected patients with diabetes OBJECTIVE To evaluate the effectiveness of systemic hyperbaric oxygen therapy ( s HBOT ) in addition to a comprehensive protocol in decreasing major amputation rate in diabetic patients hospitalized for severe foot ulcer . RESEARCH DESIGN AND METHODS From August 1993 to August 1995 , 70 diabetic subjects were consecutively admitted into our diabetologic unit for foot ulcers . All the subjects underwent our diagnostic-therapeutic protocol and were r and omized to undergo s-HBOT . Two subjects , one in the arm of the treated group and one in the arm of nontreated group , did not complete the protocol and were therefore excluded from the analysis of the results . Finally , 35 subjects received s-HBOT and another 33 did not . RESULTS Of the treated group ( mean session = 38.8 ± 8) , three subjects ( 8.6 % ) underwent major amputation : two below the knee and one above the knee . In the nontreated group , 11 subjects ( 33.3 % ) underwent major amputation : 7 below the knee and 4 above the knee . The difference is statistically significant ( P = 0.016 ) . The relative risk for the treated group was 0.26 ( 95 % CI 0.08–0.84 ) . The transcutaneous oxygen tension measured on the dorsum of the foot significantly increased in subjects treated with hyperbaric oxygen therapy : 14.0 ± 11.8 mmHg in treated group , 5.0 ± 5.4 mmHg in nontreated group ( P = 0.0002 ) . Multivariate analysis of major amputation on all the considered variables confirmed the protective role of s-HBOT ( odds ratio 0.084 , P = 0.033 , 95 % CI 0.008–0.821 ) and indicated as negative prognostic determinants low ankle-brachial index values ( odds ratio 1.715 , P = 0.013 , 95 % CI 1.121–2.626 ) and high Wagner grade ( odds ratio 11.199 , P = 0.022 , 95 % CI 1.406–89.146 ) . CONCLUSIONS s-HBOT , in conjunction with an aggressive multidisciplinary therapeutic protocol , is effective in decreasing major amputations in diabetic patients with severe prevalently ischemic foot ulcers BACKGROUND The cause of diabetic foot ulcers is multifactorial , e.g. , neuropathy and angiopathy , leading to functional disturbances in the macrocirculation and skin microcirculation . Adequate tissue oxygen tension is an essential factor in infection control and wound healing . Hyperbaric oxygen ( HBO ) therapy , daily sessions of oxygen breathing at 2.5-bar increased pressure in a hyperbaric chamber , has beneficial actions on wound healing including antimicrobial action , prevention of edema and stimulation of fibroblasts . The aim of the present study was to investigate the long-term effect of HBO in treatment of diabetic foot ulcers . METHODS Thirty-eight diabetic patients ( 30 males ) with chronic foot ulcers were investigated in a prospect i ve study . The mean age was 60+/-13 years and the mean diabetes duration 27+/-14 years . All patients were evaluated with measurements of transcutaneous oxygen tension ( tcPO(2 ) ) , peripheral blood pressure , and HbA(1c ) . All patients had a basal tcPO(2 ) value lower than 40 mmHg , which increased to > /=100 mmHg , or at least three times the basic value , during inhalation of pure oxygen . Seventeen patients underwent 40 - 60 sessions of HBO therapy , while 21 patients were treated conventionally . The follow-up time was 3 years . RESULTS 76 % of the patients treated with HBO ( Group A ) had healed with intact skin at a follow-up time of 3 years . The corresponding value for patients treated conventionally ( Group B ) was 48 % . Seven patients ( 33 % ) in Group B compared to two patients ( 12 % ) in Group A went to amputation . Peripheral blood pressure , HbA(1c ) , diabetes duration , and basal values of tcPO(2 ) were similar in both groups . CONCLUSIONS Adjunctive HBO therapy can be valuable for treating selected cases of hypoxic diabetic foot ulcers .  It seems to accelerate the rate of healing , reduce the need for amputation , and increase the number of wounds that are completely healed on long-term follow-up . Additional studies are needed to further define the role of HBO , as part of a multidisciplinary program , to preserve a functional extremity , and reduce the short- and long-term costs of amputation and disability OBJECTIVE To study the effect of systemic hyperbaric oxygenation ( HBO ) therapy on the healing course of nonischemic chronic diabetic foot ulcers .  RESEARCH DESIGN AND METHODS From 1999 to 2000 , 28 patients ( average age 60.2 + /- 9.7 years , diabetes duration 18.2 + /- 6.6 years ) , of whom 87 % had type 2 diabetes , demonstrating chronic Wagner grade s I-III foot ulcers without clinical symptoms of arteriopathy , were studied . They were r and omized to undergo HBO because their ulcers did not improve over 3 months of full st and ard treatment . All the patients demonstrated signs of neuropathy .  HBO was applied twice a day , 5 days a week for 2 weeks ; each session lasted 90 min at 2.5 ATA ( absolute temperature air ) . The main parameter studied was the size of the foot ulcer measured on tracing graphs with a computer . It was evaluated before HBO and at day 15 and 30 after the baseline . RESULTS HBO was well tolerated in all but one patient ( barotraumatic otitis ) . The transcutaneous oxygen pressure ( TcPO(2 ) ) measured on the dorsum of the feet of the patients was 45.6 + /- 18.1 mmHg ( room air ) . During HBO , the TcPO(2 ) measured around the ulcer increased significantly from 21.9 + /- 12.1 to 454.2 + /- 128.1 mmHg ( P < 0.001 ) . At day 15 ( i.e. , after completion of HBO ) , the size of ulcers decreased significantly in the HBO group ( 41.8 + /- 25.5 vs. 21.7 + /- 16.9 % in the control group [ P = 0.037 ] ) . Such a difference could no longer be observed at day 30 ( 48.1 + /- 30.3 vs. 41.7 + /- 27.3 % ) . Four weeks later , complete healing was observed in two patients having undergone HBO and none in the control group . CONCLUSIONS In addition to st and ard multidisciplinary management , HBO doubles the mean healing rate of nonischemic chronic foot ulcers in selected diabetic patients . The time dependence of the effect of HBO warrants further investigations OBJECTIVE ischaemic lower-extremity ulcers in the diabetic population are a source of major concern because of the associated high risk of limb-threatening complications . The aim of this study was to evaluate the role of hyperbaric oxygen in the management of these ulcers . METHOD eighteen diabetic patients with ischaemic , non-healing lower-extremity ulcers were recruited in a double-blind study . Patients were r and omly assigned either to receive 100 % oxygen ( treatment group ) or air ( control group ) , at 2.4 atmospheres of absolute pressure for 90 min daily ( total of 30 treatments ) . RESULTS healing with complete epithelialisation was achieved in five out of eight ulcers in the treatment group compared to one out of eight ulcers in the control group . The median decrease of the wound areas in the treatment group was 100 % and in the control group was 52 % ( p=0.027 ) . Cost-effectiveness analysis has shown that despite the extra cost involved in using hyperbaric oxygen , there was a potential saving in the total cost of treatment for each patient during the study . CONCLUSION hyperbaric oxygen enhanced the healing of ischaemic , non-healing diabetic leg ulcers and may be used as a valuable adjunct to conventional therapy when reconstructive surgery is not possible CONTEXT Concerns about the safety and efficacy of diabetes interventions persist , in part because r and omized clinical trials ( RCTs ) have not measured their effect on patient-important outcomes , ie , death and quality of life ( morbidity , pain , function ) . OBJECTIVE To systematic ally determine the extent to which ongoing and future RCTs in diabetes will ascertain patient-important outcomes . DATA SOURCES On November 10 , 2007 , we search ed primary RCT registries Clinical Trials.gov ( http://www . clinical trials.gov ) , International St and ard R and omized Controlled Trial Number Register ( http://is rct n.org ) , and Australian New Zeal and Clinical Trials Registry ( http://www.anzctr.org.au ) . STUDY SELECTION We identified phase 2 through 4 RCTs  enrolling patients with diabetes . Of 2019 RCTs , 1054 proved eligible . We r and omly sample d 50 % of the eligible RCTs ( 527 of 1054 ) and selected 436 registered since registration became m and atory ( 2004 ) . D 
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Neither  iloprost  nor pentoxifylline had a significant effect on amputation rate compared with conventional therapy .
There is low- to moderate- quality evidence supporting the use of HBOT as an adjunctive therapy to enhance diabetic foot ulcer healing and potentially prevent amputation .
However , there are only sparse data regarding the efficacy of arterial pump devices and pharmacologic interventions