Mark L.J. Arts

Effect of Custom-made Footwear on Foot Ulcer Recurrence in Diabetes: A multicenter randomized controlled trial

OBJECTIVE Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence. RESEARCH DESIGN AND METHODS We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken. RESULTS On the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk −11%, odds ratio 0.80 [95% CI 0.44–1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk −46%, odds ratio 0.38 [0.15–0.99], P = 0.045). CONCLUSIONS Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended.

Risk Factors for Plantar Foot Ulcer Recurrence in Neuropathic Diabetic Patients

OBJECTIVE Recurrence of plantar foot ulcers is a common and major problem in diabetes but not well understood. Foot biomechanics and patient behavior may be important. The aim was to identify risk factors for ulcer recurrence and to establish targets for ulcer prevention. RESEARCH DESIGN AND METHODS As part of a footwear trial, 171 neuropathic diabetic patients with a recently healed plantar foot ulcer and custom-made footwear were followed for 18 months or until ulceration. Demographic data, disease-related parameters, presence of minor lesions, barefoot and in-shoe plantar peak pressures, footwear adherence, and daily stride count were entered in a multivariate multilevel logistic regression model of plantar foot ulcer recurrence. RESULTS A total of 71 patients had a recurrent ulcer. Significant independent predictors were presence of minor lesions (odds ratio 9.06 [95% CI 2.98–27.57]), day-to-day variation in stride count (0.93 [0.89–0.99]), and cumulative duration of past foot ulcers (1.03 [1.00–1.06]). Significant independent predictors for those 41 recurrences suggested to be the result of unrecognized repetitive trauma were presence of minor lesions (10.95 [5.01–23.96]), in-shoe peak pressure <200 kPa with footwear adherence >80% (0.43 [0.20–0.94]), barefoot peak pressure (1.11 [1.00–1.22]), and day-to-day variation in stride count (0.91 [0.86–0.96]). CONCLUSIONS The presence of a minor lesion was clearly the strongest predictor, while recommended use of adequately offloading footwear was a strong protector against ulcer recurrence from unrecognized repetitive trauma. These outcomes define clear targets for diabetic foot screening and ulcer prevention.

Twelve steps per foot are recommended for valid and reliable in-shoe plantar pressure data in neuropathic diabetic patients wearing custom made footwear

BACKGROUND Dynamic in-shoe plantar pressure assessment is used both in research and clinical practice to evaluate therapeutic footwear interventions in neuropathic diabetic patients. The aim was to determine the required number of footsteps for reliable and valid in-shoe plantar pressure data in these patients. METHODS In 30 neuropathic diabetic patients wearing custom-made therapeutic footwear, in-shoe plantar pressures were measured for a minimum of 20 midgait walking steps per foot. For each incremental number of steps and for each of six anatomical regions per foot, peak pressure, pressure-time integral, contact area, contact time, and force-time integral were calculated. Reliability was assessed by calculating intraclass correlation coefficients. Validity was assessed by calculating the coefficient of variation between each n-step protocol and the 20-step reference protocol based on Limits of Agreement analysis. Data was considered reliable with intraclass correlation coefficients >0.90 and valid with coefficients of variation <10%. FINDINGS Three steps per foot were required to obtain reliable data for each foot region and parameter. Depending on the parameter, between 7 and 17 steps per foot were required to obtain valid data. With the exception of deviant outcomes in three forefoot regions for force-time integral, overall 12 steps per foot were required for valid data. INTERPRETATION For neuropathic diabetic patients wearing custom-made therapeutic footwear, 12 midgait steps per foot are required to obtain valid and reliable in-shoe plantar pressure data. This provides directions for the use of in-shoe plantar pressure analysis in research and clinical practice in this patient group.

Pressure-reduction and preservation in custom-made footwear of patients with diabetes and a history of plantar ulceration

Diabet. Med. 29, 1542–1549 (2012)

Offloading effect of therapeutic footwear in patients with diabetic neuropathy at high risk for plantar foot ulceration

Diabet. Med. 29, 1534–1541 (2012)

The efficacy of a removable vacuum-cushioned cast replacement system in reducing plantar forefoot pressures in diabetic patients

BACKGROUND The purpose of this study was to determine the plantar forefoot offloading efficacy of a new prefabricated vacuum-cushioned cast replacement system designed for foot ulcer treatment in neuropathic diabetic patients. METHODS Fifteen diabetic subjects with peripheral neuropathy underwent in-shoe plantar pressure assessment while walking in five different footwear types: a standard vacuum-cushioned system with instantly moldable vacuum cushion and roller outsole, two modified vacuum-cushioned systems, one with flat surface vacuum cushion and one with flat outsole, a forefoot offloading shoe, and a control shoe. Regional peak pressures, pressure-time integrals, and inter-regional load transfers were calculated to determine the mechanical action of the footwear. Perceived walking comfort was tested using a 10-point visual analogue scale. FINDINGS Forefoot peak pressures and pressure-time integrals were significantly lower (by 41-56%) in the vacuum-cushioned system compared to control. Compared to the forefoot offloading shoe, the vacuum-cushioned system showed significantly higher metatarsal head peak pressures, similar metatarsal head pressure-time integrals, and significantly lower hallux peak pressures and pressure-time integrals. A major transfer of forefoot load to the midfoot explained the offloading efficacy of the vacuum-cushioned system. Few significant differences were present between the modified and standard vacuum-cushioned systems. Perceived walking comfort was significantly higher in the vacuum-cushioned system (score 6.6) than in the forefoot offloading shoe (score 3.4). INTERPRETATION The results showed that the vacuum-cushioned cast replacement system was effective in offloading the plantar forefoot of diabetic patients at risk for ulceration, although the contribution of the instantly moldable vacuum cushion and roller outsole were relatively small. The combined peak pressure, pressure-time integral and walking comfort results indicate that the vacuum-cushioned system may be a useful alternative for the forefoot offloading shoe in offloading the plantar diabetic forefoot.

High satisfaction with an individualised stroke care programme after hospitalisation of patients with a TIA or minor stroke: a pilot study.

Background: Many hospitalised patients with a transient ischaemic attack (TIA) or minor stroke develop subtle cognitive disorders and emotional problems a few weeks after discharge, and are dissatisfied with the care they have received, even with specialised stroke care programmes. Therefore, an individualised stroke care programme was developed to match the therapy with the personal care needs. In this pilot study we evaluated the feasibility of the rehabilitation programme, the satisfaction of stroke patients with this programme, and the factors associated with satisfaction. Methods: Consecutive patients who were hospitalised with a TIA or minor stroke, with no apparent residual deficits, were eligible. Occupational and neuropsychological screening was applied 4–6 weeks after discharge, and therapy was provided when necessary. After 6 months, satisfaction with care (Satisfaction-With-Stroke-Care-19), was assessed as the primary outcome. Secondary outcomes were quality of life (QoL), disability, handicap, anxiety and depression. Results: 42 patients with a TIA or minor stroke participated in the programme and the follow-up. Of all the participants, 71% were satisfied with the care they have received after discharge. Male patients were more satisfied than female patients. Dissatisfied patients were less able to perform the activities of daily living, had a lower QoL and more depressive symptoms. After regression analysis, only the Barthel Index was independently associated with satisfaction. Conclusions: In this pilot study, our individualised stroke care programme seems to have improved patient satisfaction. Ability to perform daily activities is associated with satisfaction. A randomised controlled trial is needed to confirm the effectiveness of this rehabilitation programme.

Data‐driven directions for effective footwear provision for the high‐risk diabetic foot

Custom‐made footwear is used to offload the diabetic foot to prevent plantar foot ulcers. This prospective study evaluates the offloading effects of modifying custom‐made footwear and aims to provide data‐driven directions for the provision of effectively offloading footwear in clinical practice.

The effectiveness of using in-shoe plantar pressure assessment and monitoring in prescription therapeutic footwear to prevent plantar foot ulcer recurrence in diabetic patients: a multicenter randomized controlled trial

Background Diabetic patients at high risk for foot ulceration are often prescribed with custom-made therapeutic footwear. However, the evidence base to support the use of this footwear for ulcer prevention is still meagre [1]. The lack of offloading efficacy may play a role in this. In-shoe plantar pressure assessment is a valuable tool for evaluating footwear and guiding modifications to optimize the footwear’s offloading properties [2]. The aim of this multicenter randomized trial was to assess the effectiveness of this approach and long-term pressure monitoring in prescription footwear to prevent plantar foot ulcer recurrence in neuropathic diabetic patients.

PS6 - 34. The effectiveness of offloading-improved custom-made footwear on plantar foot ulcer recurrence rate in diabetic patients: a multicenter randomized controlled trial

The aim of this study was to assess the effectiveness of custom-made footwear, of which offloading is improved based on in-shoe plantar pressure analysis, in preventing plantar foot ulcer recurrence in high-risk diabetic patients.