The efficacy of removable devices to offload and heal neuropathic plantar forefoot ulcers in people with diabetes: a single-blinded multicentre randomised controlled trial.

Non-removable offloading is the 'gold standard' treatment for neuropathic diabetic plantar forefoot ulcers. However, removable offloading is the common 'standard of care'. We compared three removable offloading devices for ulcer healing efficacy. In this multicentre, randomised controlled trial, 60 persons with neuropathic diabetic plantar forefoot ulcers were randomly assigned to wear a custom-made knee-high cast [BTCC (bivalved TCC)], custom-made ankle-high cast shoe or a prefabricated ankle-high forefoot-offloading shoe (FOS). Primary outcome was healing at 12 weeks. Dynamic plantar pressures, daily stride count and treatment adherence were assessed on a randomly selected subset (n = 35). According to intention-to-treat analysis, 58% of patients healed with BTCC [OR 0·77 (95% CI 0·41-1·45) versus FOS], 60% with cast shoe [OR 0·81 (95% CI 0·44-1·49) versus FOS] and 70% with FOS (P = 0·70). Mean ± SD peak pressure in kPa at the ulcer site was 81 ± 55 for BTCC, 176 ± 80 for cast shoe and 107 ± 52 for FOS (P = 0·005); stride count was 4150 ± 1626, 3514 ± 1380 and 4447 ± 3190, respectively (P = 0·71); percentage of 2-week intervals that patients wore the device <50% of time was 17·3%, 5·2% and 4·9%, respectively. Non-significant differences in healing efficacy between the three devices suggest that, when non-removable offloading is contraindicated or not available, each can be used for plantar forefoot ulcer offloading. Efficacy is lower than previously found for non-removable offloading maybe because suboptimal adherence and high stride count expose the patient to high repetitive stresses. These factors should be carefully considered in decision making regarding ulcer treatment.

Diabetic complications do not hamper improvement of health-related quality of life over the course of treatment of diabetic foot ulcers - the Eurodiale study.

AIMS: Diabetic complications, and in particular diabetic foot ulcers (DFUs), are associated with low health-related quality of life (HRQoL). We evaluated whether the presence of diabetic complications also influenced the improvement of HRQoL during DFU treatment. METHODS: 1088 patients presenting for DFU treatment at the centers participating in the Eurodiale study were followed prospectively up to one year. HRQoL was measured both at presentation and after healing or at end of follow up, using EQ-5D: a standardized instrument consisting of five domains and a summary index. The influence of diabetic comorbidity on the course of HRQoL was evaluated for each of the EQ-5D outcomes in multi-level linear regression analyses, adjusting for baseline characteristics. RESULTS: HRQoL improved in all EQ-5D outcomes over the course of treatment for those DFUs that healed. The few significant differences in the development of HRQoL between patients with and without comorbidity showed a more beneficial development for patients with comorbidity in DFUs that did not heal or healed slowly. CONCLUSIONS: Comorbidity does not hamper improvement of HRQoL in DFU treatment. On the contrary, HRQoL improved sometimes more in patients with certain comorbidity with hard-to-heal ulcers.

Predictors of lower-extremity amputation in patients with an infected diabetic foot ulcer.

OBJECTIVE: Infection commonly complicates diabetic foot ulcers and is associated with a poor outcome. In a cohort of individuals with an infected diabetic foot ulcer, we aimed to determine independent predictors of lower-extremity amputation and the predictive value for amputation of the International Working Group on the Diabetic Foot (IWGDF) classification system and to develop a risk score for predicting amputation. RESEARCH DESIGN AND METHODS: We prospectively studied 575 patients with an infected diabetic foot ulcer presenting to 1 of 14 diabetic foot clinics in 10 European countries. RESULTS: Among these patients, 159 (28%) underwent an amputation. Independent risk factors for amputation were as follows: periwound edema, foul smell, (non)purulent exudate, deep ulcer, positive probe-to-bone test, pretibial edema, fever, and elevated C-reactive protein. Increasing IWGDF severity of infection also independently predicted amputation. We developed a risk score for any amputation and for amputations excluding the lesser toes (including the variables sex, pain on palpation, periwound edema, ulcer size, ulcer depth, and peripheral arterial disease) that predicted amputation better than the IWGDF system (area under the ROC curves 0.80, 0.78, and 0.67, respectively). CONCLUSIONS: For individuals with an infected diabetic foot ulcer, we identified independent predictors of amputation, validated the prognostic value of the IWGDF classification system, and developed a new risk score for amputation that can be readily used in daily clinical practice. Our risk score may have better prognostic accuracy than the IWGDF system, the only currently available system, but our findings need to be validated in other cohorts.

Health-related quality of life predicts major amputation and death, but not healing, in people with diabetes presenting with foot ulcers: the Eurodiale study.

OBJECTIVE: Low health-related quality of life (HRQoL) has been consistently reported to be associated with poor prognosis for a variety of health outcomes in various settings. We aimed to evaluate whether HRQoL in patients presenting with new diabetic foot ulcers (DFUs) has prognostic significance for ulcer healing, major amputation, and death. RESEARCH DESIGN AND METHODS: We followed 1,088 patients with new DFUs presenting for treatment at one of the 14 centers in 10 European countries participating in the Eurodiale (European Study Group on Diabetes and the Lower Extremity) study, prospectively until healing (76.9%), major amputation (4.6%), or death (6.4%) up to a maximum of 1 year. At baseline, patient and ulcer characteristics were recorded as well as EQ-5D, a standardized instrument consisting of five domains and a visual analog scale for use as a measure of HRQoL. The prognostic influence of the EQ-5D domains was evaluated in multivariable Cox regression analyses on the time-to-event data, adjusting for baseline clinical characteristics of the ulcer and comorbidities. RESULTS: While predictive effects of HRQoL, adjusted for possible confounders, were absent for healing, decreased HRQoL, especially in the physical domains, was statistically significant for major amputation (mobility, self-care, usual activities) and death (self-care, usual activities, pain/discomfort). CONCLUSIONS: Low HRQoL appears to be predictive for major amputation and death, but high HRQoL does not increase healing. Future studies into the influence of HRQoL on ulcer outcome are important in attempts to decrease treatment failure and mortality.

Review: The diabetic bone: a cellular and molecular perspective.

With the increasing worldwide prevalence of diabetes the resulting complications, their consequences and treatment will lead to a greater social and financial burden on society. One of the many organs to be affected is bone. Loss of bone is observed in type 1 diabetes, in extreme cases mirroring osteoporosis, thus a greater risk of fracture. In the case of type 2 diabetes, both a loss and an increase of bone has been observed, although in both cases the quality of the bone overall was poorer, again leading to a greater risk of fracture. Once a fracture has occurred, healing is delayed in diabetes, including nonunion. The reasons leading to such changes in the state of the bone and fracture healing in diabetes is under investigation, including at the cellular and the molecular levels. In comparison with our knowledge of events in normal bone homeostasis and fracture healing, that for diabetes is much more limited, particularly in patients. However, progress is being made, especially with the use of animal models for both diabetes types. Identifying the molecular and cellular changes in the bone in diabetes and understanding how they arise will allow for targeted intervention to improve diabetic bone, thus helping to counter conditions such as Charcot foot as well as preventing fracture and accelerating healing when a fracture does occur.

Optimal organization of health care in diabetic foot disease: introduction to the Eurodiale study.

This article describes the rationale and protocol of a large data collection study in patients with new diabetic foot ulcers by the Eurodiale study group, a consortium of centers of expertise in the field of diabetic foot disease within Europe. This study is a multicenter, observational, prospective data collection study. Its main aim is to determine the major factors determining clinical outcome and outcome in terms of health-related quality of life and health care consumption. Between September 1, 2003, and October 1, 2004, in 14 European centers, all consecutive patients with diabetes and a new foot ulcer were included in the study and followed until the end point or for a maximum of 1 year. End points were healing of the foot, major amputation, or death. Data were collected on patient, foot, and ulcer characteristics and on diagnostic and management procedures. Furthermore, data were collected on health care organization, quality of life, and resource use. A total of 1232 patients were included in the study. Sixty-three percent of the patients were referred by their general practitioner or were self-referrals. Twenty-seven percent of the patients were admitted at the time of inclusion; 1088 patients were followed until the end point. "Optimal Organization of Health Care in Diabetic Foot Disease" is one of the first large multicenter studies in the field of diabetic foot disease on clinical presentation, clinical outcome, quality of life, resource utilization, and health care organization and their interrelationships. These data will provide us with new insights that enable us to improve care for these patients and guide the development of new studies in this area. The results of this study are the subject of a separate presentation.

Body weight, blood pressure, and mortality in a cohort of obese patients.

The associations between body weight, raised blood pressure, and mortality remain controversial. The authors examined these relations by considering all degrees of obesity in the Düsseldorf Obesity Mortality Study (1961-1994). Among 6,193 obese German patients aged 18-75 years and having a body mass index (BMI) of > or =25 kg/m(2), 1,059 deaths were observed after a median follow-up of 14.8 years. The entire cohort was grouped into quartiles according to BMI (25-<32, 32-<36, 36-<40, > or =40 kg/m(2)) and systolic blood pressure (SBP) (<140, 140-<160, 160-<180, > or =180 mmHg). Cox proportional hazards analyses were performed to adjust for age. For women, the mortality risk curves for the four BMI groups in relation to SBP were flat without crossing, whereas the risk curve for moderately obese men (BMI 25-<32 kg/m(2)) crossed the risk curves for the higher BMI groups. In the group of patients with very high blood pressure (SBP > or = 180 mmHg), moderately obese subjects (BMI 25-<32 kg/m(2)) had a higher mortality risk for men when compared with the BMI group 32-<36 kg/m(2) (hazard ratio =1.62, 95% confidence interval: 1.0, 2.7) but not for women (hazard ratio = 0.71, 95% confidence interval: 0.4, 1.2). These findings support previous observations that the risk of death is lower for hypertensive men in high compared with low BMI groups.