Amputation-Free Survival in Patients With Diabetes Mellitus and Peripheral Arterial Disease With Heel Ulcer: Open Versus Endovascular Surgery.

BACKGROUND:: Heel ulcers in patients with diabetes mellitus (DM) and peripheral arterial disease (PAD) are hard to heal. The aim of the present study was to evaluate the difference in amputation-free survival (AFS) between open and endovascular revascularization in patients with DM, PAD, and heel ulcers. METHODS:: Retrospective comparative study of results of open versus endovascular surgery in patients with DM, PAD, and heel ulcer presented at the multidisciplinary diabetes foot clinic between 1983 and 2013. RESULTS:: Patients with heel ulcers were treated with endovascular intervention (n = 97) and open vascular surgery (n = 30). Kaplan-Meier analysis showed that the AFS was higher in patients undergoing open vascular surgery compared to the endovascular group ( P = .009). Multivariate analysis showed that open vascular surgery versus endovascular therapy (hazard ratio 2.1, 95% confidence interval 1.1-3.9; P = .025) was an independent factor associated with higher AFS. The proportion of patients undergoing endovascular therapy in the former (1983-2000) time period was 47% compared to 89% in the latter (2001-2013) time period ( P < .001). CONCLUSION:: The AFS was higher after open than endovascular surgery among patients with DM and PAD with heel ulcer. These results suggest that open vascular surgery should be offered more often as opposed to current practice.

Recurrent and other new foot ulcers after healed plantar forefoot diabetic ulcer.

Diabetic foot ulcer is a serious complication in patients with diabetes. In most outcome studies of this condition, there is a combination of various types of ulcer and ulcer locations. Plantar ulcers are usually localized to the forefoot, and constitute a quarter of all diabetic foot ulcers. There are a limited number of studies regarding development of new ulcers following healing of a plantar forefoot ulcer, and there are no uniform definitions of recurrent and other new ulcers. The aim of this study was to evaluate the outcome of a large cohort of consecutively treated patients with diabetes mellitus and a healed planter forefoot ulcer (n = 617) with regard to development, characteristics, and outcome of recurrent and other new ulcers. Patients were followed consecutively and prospectively with a 2-year follow-up, according to a preset protocol. Out of 617 patients, 250 (41%) did not develop any new ulcer, 262 (42%) developed a new ulcer, 87 (14%) died and 18 (3%) were lost at 2 years following healing of a plantar forefoot ulcer. Thirty-four percent developed other new ulcers (112 on the same foot and 99 on the contralateral foot), whereas 51 patients (8%) developed a recurrent ulcer (at the same site and foot). Of the patients who died within 2 years, 30 patients had developed other new ulcers. The risk of a recurrent ulcer in patients with diabetes and a healed plantar forefoot ulcer was only 8% within 2 years, whereas other new ulcers, on the same foot or on the contralateral foot, was seen in 4 out of 10 patients indicating the need for further preventive measures and surveillance in these patients. We suggest a concise definition for new ulcer to be used in future research.

Heel ulcers do heal in patients with diabetes.

A heel ulcer is considered to be a serious complication in patients with diabetes, and there is limited information regarding outcome. In most of the literature, a poor prognosis is described. The aim of this study was to investigate a large cohort of ulcers located in the heel in patients with diabetes. Seven hundred and sixty-eight patients [median age 73 (17-98)], presenting with a heel ulcer at a multidisciplinary diabetes foot clinic, fulfilled the inclusion criteria and were followed-up until final outcome. Fifty-eight per cent of the patients healed primarily; 7% healed after major debridement; 9% healed after amputation and 25% died unhealed. Median healing time was 17 weeks. Ulcer progression was seen in 19% of patients. Thirty-one percent of patients had severe peripheral vascular disease. A creatinine level below 91 µmol/l was related to a higher probability for healing without major debridement or amputation, whereas vascular surgery, nephropathy and oedema were related to a lower probability for healing without major debridement or amputation. Two thirds of heel ulcers do heal in patients with diabetes despite patients being elderly and with extensive comorbidity. The extent of peripheral vascular disease, nephropathy, oedema and decreased renal function are important factors influencing outcome.

High probability of healing without amputation of plantar forefoot ulcers in patients with diabetes.

Diabetic foot ulcer is an important entity which in many cases is the first serious complication in diabetes. Although a plantar forefoot location is common, there are few studies on larger cohorts and in such studies there is often a combination of various types of ulcer and ulcer locations. The purpose of this study is to discern the outcome of plantar forefoot ulcers and their specific characteristics in a large cohort. All patients (n = 770), presenting with a plantar forefoot ulcer at a multidisciplinary diabetes foot clinic from January 1, 1983 to December 31, 2012 were considered for the study. Seven hundred one patients (median age 67 [22-95]) fulfilled the inclusion criteria and were followed according to a preset protocol until final outcome (healing or death). Severe peripheral vascular disease was present in 26% of the patients and 14% had evidence of deep infection upon arrival at the foot clinic. Fifty-five percent (385/701) of the patients healed without foot surgery, 25% (173/701) healed after major debridement, 9% (60/701) healed after minor or major amputation and 12% (83/701) died unhealed. Median healing time was 17 weeks. An ulcer classified as Wagner grade 1 or 2 at inclusion and independent living were factors associated with a higher healing rate. Seventy-nine percent of 701 patients with diabetes and a plantar forefoot ulcer treated at a multidisciplinary diabetes foot clinic healed without amputation. For one third some form of foot surgery was needed to achieve healing.

The Swedish version of OMAS is a reliable and valid outcome measure for patients with ankle fractures.

BACKGROUND: The aim of this study was to evaluate the test-retest reliability and the validity of the self-reported questionnaire Olerud-Molander Ankle Score (OMAS) in subjects after an ankle fracture. METHODS: When evaluating the test-retest reliability of the OMAS, 42 subjects surgically treated due to an ankle fracture participated 12 months after injury. OMAS was completed by the patients on two occasions at one to two weeks' interval. Concurrent criterion validity was evaluated using the five subscales of the Foot and Ankle Outcome Score (FAOS) and global self-rating function (GSRF), which is a five-grade Likert scale with the alternatives: "very good", "good", "fair", "poor", "very poor". Forty-six patients participated in the validation against FAOS, and for GSRF 105 patients participated at 6 months and 99 at 12 months. Uni-, bi- and trimalleolar fractures were all included and both non-rigid and rigid surgical techniques were used. All fractures healed without complications. Before analysis of the results the five groups according to GSRF were reduced to three: "good", "fair" and "poor". Test-retest reliability was assessed using Spearman's rank correlation, the intraclass correlation coefficient (ICC), the standard error of measurement (SEM and SEM%) and the smallest real difference (SRD and SRD%). The Cronbach's alpha score and validity versus FAOS was assessed using Spearman's rank correlation and validity versus GSRF using the Kruskal-Wallis Test and the Mann-Whitney U-Test as ad hoc analyses. RESULTS: The test-retest reliability correlation coefficient obtained was rho = 0.95 and ICC = 0.94. The SEM was 4.4 points and SEM% 5.8% and should be interpreted as the smallest change that indicates a real change of clinical interest for a group of subjects. The SRD was 12 points and SRD% 15.8% and should be interpreted as the smallest change that indicates a real change of clinical interest for a single subject. The correlation coefficients versus the five subscales of FAOS ranged from rho = 0.80 to 0.86. There were significant differences between GSRF groups "good", "fair" and "poor" (p < 0.001) at both the six-month and the 12-month follow-up. The internal consistency for the OMAS was 0.76. The effect size between results from 6-month and 12-month follow-up turned out be 0.44 and should be considered as medium. CONCLUSION: The results showed that the test-retest reliability of the Swedish version of OMAS was very high in subjects after an ankle fracture and the standard error of measurement was low. Furthermore the OMAS was found to be valid using both the five subscales of FAOS and the GSRF. The OMAS can thus be used as an outcome measure after an ankle fracture.

Effects of a training program after surgically treated ankle fracture: a prospective randomised controlled trial.

BACKGROUND: Despite conflicting results after surgically treated ankle fractures few studies have evaluated the effects of different types of training programs performed after plaster removal. The aim of this study was to evaluate the effects of a 12-week standardised but individually suited training program (training group) versus usual care (control group) after plaster removal in adults with surgically treated ankle fractures. METHODS: In total, 110 men and women, 18-64 years of age, with surgically treated ankle fracture were included and randomised to either a 12-week training program or to a control group. Six and twelve months after the injury the subjects were examined by the same physiotherapist who was blinded to the treatment group. The main outcome measure was the Olerud-Molander Ankle Score (OMAS) which rates symptoms and subjectively scored function. Secondary outcome measures were: quality of life (SF-36), timed walking tests, ankle mobility tests, muscle strength tests and radiological status. RESULTS: 52 patients were randomised to the training group and 58 to the control group. Five patients dropped out before the six-month follow-up resulting in 50 patients in the training group and 55 in the control group. Nine patients dropped out between the six- and twelve-month follow-up resulting in 48 patients in both groups. When analysing the results in a mixed model analysis on repeated measures including interaction between age-group and treatment effect the training group demonstrated significantly improved results compared to the control group in subjects younger than 40 years of age regarding OMAS (p = 0.028), muscle strength in the plantar flexors (p = 0.029) and dorsiflexors (p = 0.030). CONCLUSION: The results of this study suggest that when adjusting for interaction between age-group and treatment effect the training model employed in this study was superior to usual care in patients under the age of 40. However, as only three out of nine outcome measures showed a difference, the beneficial effect from an additional standardised individually suited training program can be expected to be limited. There is need for further studies to elucidate how a training program should be designed to increase and optimise function in patients middle-aged or older. TRIAL REGISTRATION: Current Controlled Trials ACTRN12609000327280.

Sustained reduction in major amputations in diabetic patients: 628 amputations in 461 patients in a defined population over a 20-year period.

BACKGROUND AND PURPOSE: With an ageing population and an increasing incidence of diabetes, reduction of the number of diabetes-related amputations becomes increasingly difficult to achieve and maintain. There is controversy in this respect regarding the degree of success. We started a multidisciplinary treatment program for diabetic foot ulcers in 1982, and have now assessed incidence rates of amputations from 1982 through 2001. METHODS: In a defined population, gradually increasing from 199,000 to 234,000, all diabetes-related amputations of the lower extremity from toe to hip were recorded from January 1, 1982 to December 31, 2001, using several sources of information. RESULTS: The incidence of major amputations decreased by 0.57 from 16 (11-22) to 6.8 (6.1-7.5) per 100,000 inhabitants between the first and last 4-year period. The most substantial decrease was seen in patients aged 80 years and older. The fraction of amputations with a final level at or below the ankle (n = 240) increased from 0.23 in the first 4-year period to 0.31, 0.49, 0.47, and 0.49 in the following 4-year periods. The overall fraction of re-amputation was 0.34 in the first 4- year period and 0.27, 0.21, 0.32, and 0.21 in the following 4-year periods. The fraction of amputations in diabetic patients that were channeled through the footcare team prior to amputation increased from 0.51 in the first 4- year period to 0.83, 0.86, 0.90, and 0.90 in the following 4-year periods. INTERPRETATION: Our findings indicate that a substantial decrease in the incidence of major lower extremity amputations in diabetic patients has been achieved and maintained.

The value of debridement and Vacuum-Assisted Closure (V.A.C.) Therapy in diabetic foot ulcers.

BACKGROUND: Treatment of diabetic foot ulcers includes a number of different regimes such as glycaemic control, re-vascularization, surgical, local wound treatment, offloading and other non-surgical treatments. Although considered the standard of care, the scientific evidence behind the various debridements used is scarce. This presentation will focus on debridement and V.A.C. Therapy, two treatments widely used in patients with diabetes and foot ulcers. METHODS: A review of existing literature on these treatments in diabetic foot ulcers, with focus on description of the various types of debridements used, the principles behind negative pressure wound therapy (NPWT) using the V.A.C. Therapy system and level of evidence. RESULTS: Five randomized controlled trials (RCT) of debridement were identified; three assessed the effectiveness of a hydrogel as a debridement method, one evaluated surgical debridement and one evaluated larval therapy. Pooling the three hydrogel RCTs suggested that hydrogels are significantly more effective than gauze or standard care in healing diabetic foot ulcers. Surgical debridement and larval therapy showed no significant benefit. Other debridement methods such as enzyme preparations or polysaccharide beads have not been evaluated in RCTs of people with diabetes. More than 300 articles have been published on negative pressure wound therapy, including several small RCTs and a larger multi-centre RCT of diabetic foot ulcers. Negative pressure wound therapy seems to be a safe and effective treatment for complex diabetic foot wounds, and could lead to a higher proportion of healed wounds, faster healing rates, and potentially fewer re-amputations than standard care. CONCLUSIONS: Although debridement of the ulcer is considered a prerequisite for healing of diabetic foot ulcers, the grade of evidence is quite low. This may be due to a lack of studies rather than lack of effect. Negative pressure wound therapy seems to be safe and effective in the treatment of some diabetic foot ulcers, although there is still only one well-performed trial that evaluates the effect.

Outcome and quality of life after surgically treated ankle fractures in patients 65 years or older.

BACKGROUND: Despite high incidence of ankle fractures in the elderly, studies evaluating outcome and impact of quality of life in this age group specifically are sparse. The aim of this study was to evaluate outcome and quality of life 6 and 12 months after injury in patients 65 years or older who had been operated on due to an ankle fracture. METHODS: Sixty patients 65 years or older were invited to participate in the study. 6 and 12 months after the injury a questionnaire including inquiry to participate, the Olerud-Molander Ankle Score (OMAS), Short-Form 36 (SF-36), Linear Analogue Scale (LAS), Self-rated Ankle Function and some supplementary questions was sent home to the patients. The supplementary questions concerned subjective experience of ankle instability, sporting and physical activity level before injury and recaptured activity level at follow-ups, need of walking aid before injury, state of living before injury and at follow-ups and co-morbidities. After the 12-month follow-up the patients were also called for a radiological examination. RESULTS: Fifty patients (83%) answered the questionnaire at 6-month and 46 (77%) at the 12-month follow-up. Although, 45 (90%) fractures were low-energy trauma 44 (88%) were bi- or trimalleolar and post-operative reduction results were complete in 23 (46%) ankles. The median OMAS improved from 60 (Interquartile range (IQR) 36) at 6-month to 70 (IQR 35) at 12-month (p = 0.002), but at 12-month still sixty percent or more of the patients reported pain, swelling, problems when stair-climbing and reduced activities of daily life. Twenty (40%) rated their ankle function as 'good' or 'very good' at 6-month and 30 (60%) at 12-month. Forty-one (82%) were physically active before injury but still one year after only 18/41 had returned to their pre-injury physical activity level. According to SF-36 four dimensions differed from the age- and gender matched normative data of the Swedish population, 'physical function', 'role physical' and 'role emotional' were below norms at 6-month for women (p = 0.010, p = 0.024 and 0.031) and 'general health' was above norms at 12-month for men (p = 0.044). CONCLUSION: One year after surgically treated ankle fractures a majority of patients continue to have symptoms and reported functional limitations. However, SF-36 scores indicate that only females had functional status below the age- and gender matched normative data of the Swedish population.

Nutritional supplementation decreases hip fracture-related complications.

Protein energy malnutrition is an important determinant of clinical outcome in older patients after hip fracture, but the effectiveness of nutritional support programs in routine clinical practice is controversial. We performed a prospective, randomized, controlled clinical trial to determine if nutritional supplementation decreased fracture-related complications in a selection of otherwise healthy patients with hip fractures. Patients were randomized to intervention or control groups. The control group (n = 40) was given ordinary hospital food and beverage. The intervention group (n = 40) also was administered a 1000 kcal daily intravenous supplement for 3 days, followed by a 400 kcal oral nutritional supplement for 7 days. We recorded daily fluid and energy intake during the first 10 days of hospitalization and fracture-related complications up to 4 months. The total fluid and energy intake in the intervention group neared optimal levels. The control group received 54% and 64% of optimal energy and fluid intake, respectively. The risk of fracture- related complications was greater in the control group (70%) than in the intervention group (15%). Four patients in the control group died within 120 days postoperatively. The comprehensive balanced nutrition supplement resulted in lower complication rates and mortality at 120 days postoperatively.

Balance in single-limb stance after surgically treated ankle fractures: a 14-month follow-up.

BACKGROUND: The maintenance of postural control is fundamental for different types of physical activity. This can be measured by having subjects stand on one leg on a force plate. Many studies assessing standing balance have previously been carried out in patients with ankle ligament injuries but not in patients with ankle fractures. The aim of this study was to evaluate whether patients operated on because of an ankle fracture had impaired postural control compared to an uninjured age- and gender-matched control group. METHODS: Fifty-four individuals (patients) operated on because of an ankle fracture were examined 14 months postoperatively. Muscle strength, ankle mobility, and single-limb stance on a force-platform were measured. Average speed of centre of pressure movements and number of movements exceeding 10 mm from the mean value of centre of pressure were registered in the frontal and sagittal planes on a force-platform. Fifty-four age- and gender-matched uninjured individuals (controls) were examined in the single-limb stance test only. The paired Student t-test was used for comparisons between patients' injured and uninjured legs and between side-matched legs within the controls. The independent Student t-test was used for comparisons between patients and controls. The Chi-square test, and when applicable, Fisher's exact test were used for comparisons between groups. Multiple logistic regression was performed to identify factors associated with belonging to the group unable to complete the single-limb stance test on the force-platform. RESULTS: Fourteen of the 54 patients (26%) did not manage to complete the single-limb stance test on the force-platform, whereas all controls managed this (p < 0.001). Age over 45 years was the only factor significantly associated with not managing the test. When not adjusted for age, decreased strength in the ankle plantar flexors and dorsiflexors was significantly associated with not managing the test. In the 40 patients who managed to complete the single-limb stance test no differences were found between the results of patients' injured leg and the side-matched leg of the controls regarding average speed and the number of centre of pressure movements. CONCLUSION: One in four patients operated on because of an ankle fracture had impaired postural control compared to an age- and gender-matched control group. Age over 45 years and decreased strength in the ankle plantar flexors and dorsiflexors were found to be associated with decreased balance performance. Further, longitudinal studies are required to evaluate whether muscle and balance training in the rehabilitation phase may improve postural control.

Nonoperative treatment of Achilles tendon rupture: 196 consecutive patients with a 7% re-rupture rate.

BACKGROUND: The best treatment for acute Achilles tendon rupture is unknown. PATIENTS AND METHODS: We assessed the outcome of nonoperative treatment in 196 consecutive individuals with an acute total Achilles tendon rupture who were followed until healing. The mean duration of treatment in cast or orthosis was 8 weeks. After 4 years, a questionnaire was sent to all patients who were still alive (182) to supplement and confirm the retrospective data. The questionnaire was completed by 176/182 patients (97%). RESULTS: The re-rupture frequency was 7% (n = 14). 7 patients suffered other complications (7 deep venous thrombosis and 1 pulmonary embolism). At follow-up, 62% of the patients reported full recovery. INTERPRETATION: The low re-rupture rate after nonoperative treatment challenges the claim in recent studies that acute rupture of the Achilles tendon should be operated.

Insufficient fluid and energy intake in hospitalised patients with hip fracture. A prospective randomised study of 80 patients.

AIMS: Evaluate nutritional status and fluid and energy intake during the first ten days of hospitalisation in a selection of otherwise healthy patients with a hip fracture. METHODS: A prospective randomised controlled study of 80 patients. Nutritional status was assessed at inclusion. The energy and fluid intake was recorded and calculated daily whilst hospitalised. All patients were given ordinary hospital food and beverage. In the treatment group (n = 40) patients also received intraveneous supplementary nutrition (1000 kcal/day) for three days followed by oral supplementary nutrition (400 kcal/day) for seven days or until discharge. RESULTS: One third of patients were classified as malnourished in both groups. The average daily fluid intake/patient was 1300 ml in the control group compared to 1856 ml in the treatment group (P<0.0001). The average daily energy intake/patient was 916 kcal in the control group compared to 1296 kcal in the treatment group (P = 0.003). The mean difference between actual and needed daily fluid intake was -739 ml in the control group and +27 ml in the treatment group (P<0.0001). Corresponding numbers for energy intake was -783 kcal/day in the control group and -228 kcal/day in the treatment group (P = 0.0003). CONCLUSIONS: Malnutrition is common even in a selection of healthy patients with hip fractures. During hospital stay the fluid and energy intake was considerably lower than that needed in the control group. Supplementary nutritional intake for ten days increased the total fluid and energy intake in the treatment group to near needed levels.

Raised serum S100B levels after acute bone fractures without cerebral injury.

BACKGROUND: S100B, a protein abundant in astroglial cells within the central nervous system, has been shown to increase in cerebrospinal fluid and serum after various neurologic diseases. However, the cerebral specificity of S100B has been questioned. This study aims to show serum S100B levels after uncomplicated bone fractures in patients without current or prior neurologic diseases. METHODS: Blood for sampling was drawn from patients seeking care at the emergency department presenting with various uncomplicated orthopedic fractures no older than 24 hours and having no previous or suspected neurologic disorder or head injury. RESULTS: Fifty-five consecutive patients with acute fractures were included in the study. Serum S100B levels were raised above 0.15 microg/L in 16 of 55 (29%) patients (range, 0.02-0.51 microg/L; mean, 0.13 +/- 0.11 microg/L). CONCLUSION: S100B levels were raised in 29% of patients with acute fractures without apparent cerebral injury, which suggests an extracerebral source of S100B. This information should be taken into account when interpreting S100B levels when dealing with brain damage.

Levofloxacin-associated Achilles tendon rupture and tendinopathy.

Fluoroquinolones have a documented ability to induce Achilles tendinopathy. Hitherto, few published reports have implicated levofloxacin. This article reports 5 cases of Achilles tendon disorders, including 3 complicated by rupture of the tendon, during levofloxacin treatment of patients with chronic obstructive pulmonary disease.

Performance after surgical treatment of patients with ankle fractures--14-month follow-up.

BACKGROUND AND PURPOSE: Few studies have been published that extensively evaluate physical outcome after ankle fractures. In addition, there is a lack of knowledge of how physical outcome correlates with subjective assessments of symptoms and function after ankle fracture. The purpose of the present study was to investigate outcome after surgical treatment of patients with ankle fracture and to study how well the experience of symptoms and function correlated with the results of clinical physical tests. METHOD: The study used a retrospective cross-sectional study design. Fifty-four patients, aged 17-64 years, were evaluated 14 months post-operatively. Evaluation included a questionnaire containing the Olerud-Molander Ankle Score (OMAS) (Olerud and Molander, 1984) and some additional questions. Patients were also called for a physical and radiographic examination. RESULTS: The median OMAS obtained was 75 (range 10-100). Only 10 (19%) of the patients reported complete recovery and 16 (30%) scored > or = 90, indicating good function. The results of the following clinical tests were correlated with OMAS: loaded dorsal extension; ankle circumference; number of toe and heel rises; and single-limb stance. Those who showed poorer results in physical outcome on the affected side had lower OMAS. No ankles with clear mechanical instability were found, although almost half the patients experienced functional instability that, in turn, was associated with decreased total OMAS. CONCLUSIONS: Both subjectively scored function and physical performance after surgically treated ankle fractures indicated poor results. One reason for this might be insufficient rehabilitation.