Minor amputation in patients with diabetes mellitus and severe foot ulcers achieves good outcomes.

OBJECTIVE: To analyse the outcome of minor amputations (through, or distal to, the ankle joint) in patients with diabetes. METHOD: All diabetic patients in a defined population undergoing one or more minor amputation between 1982 and 2006 were investigated according to a standardised protocol and were followed until final outcome (healing or death). A total of 410 consecutive amputations in 309 patients with a median age of 73 (32-93) years were identified. RESULTS: In 94% of amputations, deep infection (39%) and/or gangrene (55%) was present. Severe peripheral vascular disease or critical limb ischaemia was present in 61% of amputations. 261/410 (64%) of the amputations healed at a level below the ankle joint; 69/410 (17%) healed after a re-amputation above the ankle joint; in 76/410 of amputations (19%), the patient died before healing could occur. In surviving patients, 79% of the amputations healed below the ankle. Median healing time for amputations that healed below the ankle was 26 (2-250) weeks; 21% of amputations required a re-amputation above the ankle. None of the analysed parameters excluded the possibility of healing below the ankle. CONCLUSION: In this population-based survey, the goal of avoiding major amputation was achieved in almost two thirds of minor amputations, but at the price of long healing times. In almost all amputations, the patient had deep infection and/or gangrene. In spite of this, 64% of all amputations, and 79% of amputations in surviving patients, healed at a level below the ankle. This indicates that minor amputations in these patients are worthwhile. DECLARATION OF INTEREST: None.

Complexity of factors related to outcome of neuropathic and neuroischaemic/ischaemic diabetic foot ulcers: a cohort study.

AIMS/HYPOTHESIS: We sought to identify factors related to short-term outcome of foot ulcers in patients with diabetes treated in a multidisciplinary system until healing was achieved. METHODS: Consecutively presenting patients with diabetes and worst foot ulcer (Wagner grade 1-5, below ankle) (n = 2,511) were prospectively followed and treated according to a standardised protocol until healing was achieved or until death. The number of patients lost to dropout was 31. The characteristics of the remaining 2,480 patients were: 1,465 men, age 68 +/- 15 years (range 18-96), type 1 diabetes 18%, type 2 diabetes 82% and insulin-treated 62%. RESULTS: The healing rate without major amputation in surviving patients was 90.6% (n = 1,867). Sixty-five per cent (n = 1,617) were healed primarily, 9% (n = 250) after minor amputation and 8% after major amputation; 17% (n = 420) died unhealed. Out of 2,060 surviving patients, 1,007 were neuroischaemic (48.8%). In a multiple regression analysis, primary healing was related to co-morbidity, duration of diabetes, extent of peripheral vascular disease and type of ulcer. In neuropathic ulcers, deep foot infection, site of ulcer and co-morbidity were related to amputation. Amputation in neuroischaemic ulcers was related to co-morbidity, peripheral vascular disease and type of ulcer. Age, sex, duration of diabetes, neuropathy, deformity and duration of ulcer or site of ulcer did not have an evident influence on probability of amputation. CONCLUSIONS/INTERPRETATION: Patients with diabetic foot ulcer suffer from multi-organ disease. Factors related to outcome are correspondingly complex.

Diabetic foot osteomyelitis: a progress report on diagnosis and a systematic review of treatment.

The International Working Group on the Diabetic Foot appointed an expert panel to provide evidence-based guidance on the management of osteomyelitis in the diabetic foot. Initially, the panel formulated a consensus scheme for the diagnosis of diabetic foot osteomyelitis (DFO) for research purposes, and undertook a systematic review of the evidence relating to treatment. The consensus diagnostic scheme was based on expert opinion; the systematic review was based on a search for reports of the effectiveness of treatment for DFO published prior to December 2006. The panel reached consensus on a proposed scheme that assesses the probability of DFO, based on clinical findings and the results of imaging and laboratory investigations. The literature review identified 1168 papers, 19 of which fulfilled criteria for detailed data extraction. No significant differences in outcome were associated with any particular treatment strategy. There was no evidence that surgical debridement of the infected bone is routinely necessary. Culture and sensitivity of isolates from bone biopsy may assist in selecting properly targeted antibiotic regimens, but empirical regimens should include agents active against staphylococci, administered either intravenously or orally (with a highly bioavailable agent). There are no data to support the superiority of any particular route of delivery of systemic antibiotics or to inform the optimal duration of antibiotic therapy. No available evidence supports the use of any adjunctive therapies, such as hyperbaric oxygen, granulocyte-colony stimulating factor or larvae. We have proposed a scheme for diagnosing DFO for research purposes. Data to inform treatment choices in DFO are limited, and further research is urgently needed.

Nutritional supplementation for diabetic foot ulcers: the first RCT.

OBJECTIVE: To determine if oral nutritional supplementation improved wound healing in malnourished patients with diabetic foot ulcers when compared with a placebo. METHOD: This prospective randomised controlled double-blind trial involved patients aged over 60 with diabetes mellitus and a Wagner grade I-II foot ulcer of over four weeks' duration. Patients received either 400 ml (400 kcal) oral nutritional supplementation (n = 26) or 400 ml placebo (n = 27) daily for six months. Patients were followed monthly for six months and after one and two years. RESULTS: A third of the patients were classified as having protein-energy malnutrition at inclusion, with no difference between the two groups. Critical leg ischaemia was more common in the intervention group than in the placebo group (p = 0.008). Nine patients in the intervention group (35%) and four in the placebo group (15%) dropped out of the study (not significant). Of those who completed the study, the wound had healed at six months in eight out of 23 patients (41%) (placebo) and in seven out of 17 (35%) (intervention) (not significant). Twenty-four per cent of patients with protein-energy malnutrition at inclusion had healed at six months compared with 50% of those without it (not significant). CONCLUSION: This is the first study to evaluate the possible benefits of nutritional supplementation on diabetic foot ulcers. A third of patients were malnourished. We encountered several methodological problems and were unable to demonstrate an improved wound healing rate in these patients.

The inpatient care of patients with diabetes mellitus and foot ulcers. A validation study of the correspondence between medical records and the Swedish Inpatient Registry with the consequences for cost estimations.

OBJECTIVES: To compare the correspondence of discharges and diagnoses between medical records and an administrative database in diabetic patients with foot ulcers and to calculate inpatient costs from the different sources. DESIGN: Discharge data from 117 prospectively followed patients were compared with information from the Swedish Inpatient Registry during the same treatment period for each patient. Non corresponding discharges were retrospectively reviewed in patient records. Costs of inpatient care were calculated from clinical sources and from data selected in three different ways from the database. Information in medical records was assumed to represent the 'Gold Standard'. SETTING: In-hospital treatment, multidisciplinary foot-care team. SUBJECTS: A total of 117 diabetic patients with deep foot infections. MAIN OUTCOME MEASURES: Degree of database completeness and inpatient costs. RESULTS: The degree of completeness of discharges in the database was 98%, but 8.6% of discharges had no code for diabetes and 13% were registered without any foot related diagnosis code. Less than 20% of discharges were found with selection based on primary diagnosis 250.G only. Total inpatient costs varied from 2.7 to 13.3 million SEK (Swedish Kronor) depending on selected diagnosis codes. Approximately 84% of all foot ulcer discharges could be found in the database if codes with both diabetes mellitus and foot ulcer diagnoses were selected. CONCLUSIONS: Inpatient costs for foot complications cannot be accurately estimated from the Inpatient Registry when based on primary diagnosis exclusively. Fairly good estimates at a low data acquisition cost can be made with a combination of foot related diagnoses together with codes for diabetes.

Costs of deep foot infections in patients with diabetes mellitus.

OBJECTIVE: To calculate costs for the management of deep foot infections and to identify the most important factors related to treatment costs. DESIGN: Costs for in-hospital care, surgery, investigations, antibacterials, visits to the foot-care team, orthopaedic appliances and topical treatment were calculated retrospectively from diagnosis until healing or death. Multiple regression analysis was used to identify factors that independently affect costs. SETTING: A multidisciplinary foot-care team. PATIENTS: 220 prospectively followed patients with diabetes mellitus and deep foot infections who were referred to the team from 1986 to 1995. MAIN OUTCOME MEASURES AND RESULTS: Total cost for healing without amputation was Swedish kronor (SEK)136,600 per patient, while the corresponding cost for healing with minor amputation was SEK260,000 and with major amputation was SEK234,500. All costs were quoted in SEK at 1997 price levels (1 Pound sterling and $US1 equalled approximately SEK12.50 and SEK7.64, respectively). The cost of antibacterials was 4% of total costs. The cost of topical treatment was 51% of total costs and related to wound healing time. Number of weeks between diagnosis of deep foot infection and healing, and number of surgical procedures were variables that explained 95% of costs in the multiple regression analysis. It was not possible to find any parameters present at diagnosis that could contribute to an explanation of total treatment costs. CONCLUSIONS: Topical treatment accounted for the largest proportion of total costs and the most important cost driving factors were wound healing duration and repeated surgery. Costs of antibacterials should not be used as an argument in the choice between early amputation and conservative treatment.

[The diabetic foot. Optimal prevention and treatment can halve the risk of amputation]. / Diabetikers fotproblem. Rätt prevention och behandling kan halvera risken för amputation.

Almost half of all lower leg amputations are performed in patients with diabetes. In over 70 per cent of these cases, amputation is precipitated by progression of foot ulceration to deep gangrenous infection. Most foot ulcers are preceded by trauma, usually due to ill-fitting shoes, and are precipitated by sensory motor neuropathy with varying degrees of peripheral vascular disease. The Swedish Medical Research Council and the Swedish Institute for Health Services Development arranged a conference on diabetic foot problems in April 1998, the purpose of which was to arrive at a consensus regarding the prevention and management of diabetic foot. It was concluded that a satisfactory multidisciplinary approach should include regular control of feet and footwear, preventive foot care (education, footwear, chiropody), continuous follow-up of high-risk feet, and early recognition of revascularisation. Continuous registration of amputation, irrespective of type, cause and site, might substantially reduce the amputation rate among diabetics. Were such an approach to reduce the incidence of diabetes-related amputation by 50 per cent, annual costs for the management of diabetic foot in Sweden would be reduce by SEK 400 million (the value of improved quality of life not taken into consideration).

Deep foot infections in patients with diabetes and foot ulcer: an entity with different characteristics, treatments, and prognosis.

We report findings in 223 consecutively included people with diabetes, foot ulcer and a deep foot infection treated by a multidisciplinary diabetic foot care team at the University Hospital in Lund, Sweden. The aim of the present study was to evaluate type and characteristics of deep foot infections and their relation to choice of treatment and outcome. Three different groups of deep foot infections were identified; osteomyelitis only (n = 112), deep soft tissue infection only (n = 46) and combined infections (osteomyelitis and deep soft tissue infection, n = 65). The various types of deep foot infections had different characteristics, treatment and prognosis. Patients with a deep soft tissue infection only or a combined infection had a significantly (p < 0.05) higher; (1) body temperature (38.0 and 38.0 vs. 37.3 degrees C), (2) erythrocyte sedimentation rate (75 and 80 vs. 56 mm/h) and (3) white blood count (11.0 and 12.0 vs. 8 x 10(9)) at diagnosis compared with those who had osteomyelitis only. Patients with a deep soft tissue infection only or a combined infection also had a significantly (p < 0.05) shorter time to surgery (2 and 4 vs. 10 days), higher mean number of surgical procedures (1.9 and 2.1 vs. 1.4 procedures) and higher percentage of patients had intravenous antibiotics (87 and 84 vs. 46%) compared with those who had osteomyelitis only. Amputation before healing was more common in patients with a combined infection (62%) compared with those who had osteomyelitis only (37%) or a deep soft tissue infection only (30%). The findings in the present study indicate that deep foot infections in patients with diabetes is a heterogeneous entity, in which the type of deep foot infection is related to choice of treatment strategy and to outcome. Therefore, these various types of infections has to be considered in future studies of deep foot infections in people with diabetes.

Clinical characteristics and outcome in 223 diabetic patients with deep foot infections.

Clinical characteristics and outcome in 223 consecutive diabetic patients with deep foot infections are reported. Patients were treated by a multidisciplinary diabetic foot-care team at the University Hospital, Lund, Sweden, and were prospectively followed until healing or death. About 50% of patients lacked clinical signs of infection, such as a body temperature > 37.8 degrees C, a sedimentation rate > 70 mm/hour, and white blood cell count (WBC) > 10 x 10(9)/liter. Eighty-six percent had surgery before healing or death. Thirty-nine percent healed without amputation; 34% healed after a minor and 8% after a major amputation. Sixteen percent were unhealed at death, and 3% were unhealed at the end of the observation period. Of those unhealed at death or follow-up, 4 patients had had a major and 11 a minor amputation. After correction for age and sex, duration of diabetes < 14 years, palpable popliteal pulse, a toe pressure > 45 mmHg, and an ankle pressure > 80 mm Hg, absence of exposed bone and a white blood cell count < 12 x 10(9)/liter were all related to healing without amputation in a logistic regression analysis. We conclude that although only 1 in 10 had a major amputation, nearly all diabetic patients with a deep foot infection needed surgery and more than one third had a minor amputation before healing or death in spite of a well-functioning diabetic foot-care team responsible for all included patients.

Improved wound healing in transtibial amputees receiving supplementary nutrition.

The objective of this prospective study of matched controls was to find out whether supplementary nutrition would improve wound healing and decrease mortality in patients undergoing transtibial amputation for occlusive arterial disease. The nutritional status of 32 consecutive transtibial amputees was assessed and 28 were classified as malnourished. Supplementary nutrition was given reaching an average intake of 2098 kcal/day for a total of 11 days. In 24 patients, at least 5 days of preoperative supplementary nutrition were given, followed by postoperative treatment for a total of 11 days. Four patients who had an immediate operation were given only postoperative treatment, and 4 were excluded. The controls were 32 amputees in another hospital and matching procedures were carried out with corrections for diabetes, sex, age, smoking habits, previous vascular surgery and living conditions before amputation. Healing, including those healed before death in both groups, occurred in 26 of the nutrition group compared to 13 in the control group, which was statistically significant. Nine patients died within 6 months in the nutrition group compared to 14 of the controls (not significant). Malnutrition was present in nearly 90% of transtibial amputees and supplementary nutrition improved healing, but not mortality.

Operations, total hospital stay and costs of critical leg ischemia. A population-based longitudinal outcome study of 321 patients.

In a longitudinal analysis of all 321 patients in a defined population having surgery for critical leg ischemia during 1 year in Malmöhus county (0.53 million inhabitants), Sweden, we investigated all vascular procedures and amputations on both legs, total hospital stay and hospital costs from the first procedure in each patient until death or at follow-up at least 6 years postoperatively. The first (key) operation during the inclusion year was a reconstructive vascular procedure in 96 patients, a restorative vascular procedure in 111 and a major amputation in 114 patients. One third of those with a reconstructive and half of those with a restorative key procedure had an ipsilateral major amputation. The mean number of surgical procedures and length of hospital stay among all patients were 3 (1-19) procedures and 117 (1-1097) days, respectively. Of the total number of days in hospital, less than half were in surgical departments, 10% in other acute-care departments and almost half in rehabilitation clinics and nursing homes. The total hospital and surgical costs among all patients were USD 15.1 million (mean USD 47,000/patient), with no significant differences in relation to the key operation. We conclude that patients who have undergone surgery for critical leg ischemia accumulate very high total long-term hospital costs due to the need for repetitive surgery and long hospital stays. Our findings also show that a longitudinal study, including hospital stay in departments other than surgical, is necessary for a correct cost-and-outcome analysis.

Risk factors for failed healing in amputation for vascular disease. A prospective, consecutive study of 177 cases.

We examined factors which may lower the mean amputation age and factors which may serve as predictors of success or failure of amputations in the lower extremities for vascular disease in 177 consecutive amputees. Smoking lowered the mean amputation age by 9 years and diabetes by 3 years. Preoperative absence of gangrene in the ischemic limb predicted a higher risk of failure compared to patients with gangrene. Also preoperative hemoglobin > 120 g/L gave a higher risk of failure. Failure to heal was not correlated with age, sex, diabetes, level of amputation, previous vascular surgery, smoking, preoperative blood pressure, serum creatinine, erythrocyte sedimentation rate, blood glucose or temperature.

Amputation for occlusive arterial disease. A prospective multicentre study of 177 amputees.

All major amputations of the lower limb due to occlusive arterial disease were studied prospectively and consecutively during one year in the 5 hospitals in Malmöhus county, Sweden. The patients were followed for 6 months after the primary amputation of which 136 were through the tibia, 6 through the knee and 35 through the femur. One hundred and seventy-seven patients (92 men and 85 women) were included; 49% were 80 years or older and 40% were diabetic. At 6 months, 85 of the surviving 109 patients had healed stumps, 10 were not healed and 14 had been revised or reamputated. Half the survivors used a prosthesis daily. There was no significant difference in healing related to sex, age, diabetes or the level of amputation, but diabetics were more often bilateral amputees. The mortality at 6 months was 38% and at 4 years 72%.

Localization of the chromosomal breakpoints of the t(12;16) in liposarcoma to subbands 12q13.3 and 16p11.2.

Short-term cultures of two myxoid liposarcomas and two mixed-type (myxoid and round cell) liposarcomas were cytogenetically analyzed. A t(12;16)(q13;p11) was present in three tumors, whereas the fourth had an unbalanced 12;16-translocation with breaks in 12q13 and 12q22, with loss of the 12q13-q22 segment, and in 16p11. In the two mixed liposarcomas, the breakpoints could be determined at subband level to 12q13.3 and 16p11.2.

Characteristic karyotypic anomalies identify subtypes of malignant fibrous histiocytoma.

Cytogenetic analysis of short-term cultures from 25 malignant fibrous histiocytomas (MFH) revealed clonal chromosome abnormalities in 17 tumors: ten storiform-pleomorphic and seven myxoid MFH. Telomeric associations, rings, and dicentric chromosomes were present in 11 tumors and cytogenetic signs of gene amplification (homogeneously staining regions and double minute chromosomes) in four. The breakpoint distribution of the numerous structural rearrangements was nonrandom. The chromosome bands most frequently affected were 19p13 (in eight tumors; eight rearrangements gave rise to 19p+ markers, some of which looked similar, and an r(19) was found in one case), 11p11 (in seven tumors; three translocations and four deletions), 1q11 (in seven tumors; one translocation and six deletions), and 3p12 (in six tumors; all deletions). Other bands involved at least four times were 1p36, 5p15, and 20q13. Of particular clinical interest was the observation that tumors with 19p+ seemed to have a pronounced tendency to recur locally (local recurrence in five of eight tumors with 19p+ compared to one of nine in tumors without this aberration; observation period 4-16 months).