Dataset Information

Study protocol for a randomized controlled trial to test for preventive effects of diabetic foot ulceration by telemedicine that includes sensor-equipped insoles combined with photo documentation.

ABSTRACT: BACKGROUND:Early detection of diabetic foot ulcerations (DFUs) can avoid or delay any progression into more severe stages, which may require limb amputation or lead to infectious sequelae and death. However, frequent clinical screening would be too intrusive and costly, and self-examination may be hampered by concomitant diseases and social disabilities. In addition, it requires professional knowledge and experience using specialized devices. Researchers reported that skin temperature monitoring could reduce the risk of DFUs in high-risk patients. The main research objects in this field are effective and convenient means of temperature measurement, accurate and reasonable early warning mechanisms, and timely and appropriate interventions. This trial aims to investigate the effectiveness of daily home-based foot temperature measurements in the prevention of DFUs with the aid of intelligent sensor-equipped insoles combined with photo documentation. METHODS/DESIGN:In this open-label, prospective, randomized, 24-month trial, 300 patients with diabetes mellitus (type 1 or 2) and severe diabetic peripheral neuropathy (vibration sensation ??4/8), aged 18-85?years, will be recruited and assigned to control and intervention groups in a ratio of 1:1. Main inclusion criteria to be eligible for study participation encompass in particular risk group 2 or 3 for the development of DFUs using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Feet [IWGDF]) and the ability to use a mobile phone. INTERVENTIONS:Participants in both groups will receive education about regular foot care at the beginning of the study (visit 0). In the intervention group, every patient will receive a pair of slippers with the inserted sensor-equipped insole as well as a smartphone with the corresponding smartphone application (Smart Prevent Diabetic Feet Application). The insole is a tool that records the temperature variabilities of the plantar foot. Patients will measure their foot temperature twice a day at home with a time interval >?4 h during the entire course of the study (24?months). The measured data will be initially analyzed and visualized, and further transferred to a remote server that allows the physician to perform specific interpretations. In case of temperature differences >?1.5?°C between left and right corresponding sites lasting >?32?h (assigned alarm level 4), the physician will start an intervention phase, which requires the patient to reduce daily activities and relax his feet for five days. At the same time, photo documentation is encouraged to be performed by the patient. Possibly, additional visits to a private doctor or clinical examinations will be arranged for the patient during this intervention period. OUTCOMES:The primary outcome is foot ulceration, evaluated by a physician, and occurring at any point during the study. DISCUSSION:This study addresses principal aspects in the prevention of DFUs. First, the sensor-equipped insole will be evaluated for daily performance in home-based measurements of foot temperatures. Second, a telemedicine structure is tested that evaluates sensor data automatically and proposes suitable intervention measures under the supervision of a physician. Third, predictive models for DFUs will be built using the collected sensor data allowing for interpretations, which in the future may support medical care providers. TRIAL REGISTRATION:German Clinical Trials Register (DRKS), DRKS00013798 . Registered on 18 January 2018.

SUBMITTER: Ming A

PROVIDER: S-EPMC6704693 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Study protocol for a randomized controlled trial to test for preventive effects of diabetic foot ulceration by telemedicine that includes sensor-equipped insoles combined with photo documentation.

Ming Antao A Walter Isabell I Alhajjar Ahmad A Leuckert Martin M Mertens Peter R PR

Trials 20190822 1

<h4>Background</h4>Early detection of diabetic foot ulcerations (DFUs) can avoid or delay any progression into more severe stages, which may require limb amputation or lead to infectious sequelae and death. However, frequent clinical screening would be too intrusive and costly, and self-examination may be hampered by concomitant diseases and social disabilities. In addition, it requires professional knowledge and experience using specialized devices. Researchers reported that skin temperature mo ...[more]

PMID: 31439007

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Project description:UnlabelledBackgroundNeuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues is reduced. Insole therapy is one practical method commonly used to reduce plantar loads and ulceration risk. The type of insole best suited to achieve this is unknown. This trial compared custom-made functional insoles with prefabricated insoles to reduce risk factors for ulceration of neuropathic diabetic feet.MethodA participant-blinded randomised controlled trial recruited 119 neuropathic participants with diabetes who were randomly allocated to custom-made functional or prefabricated insoles. Data were collected at issue and six month follow-up using the F-scan in-shoe pressure measurement system. Primary outcomes were: peak pressure, forefoot pressure time integral, total contact area, forefoot rate of load, duration of load as a percentage of stance. Secondary outcomes were patient perceived foot health (Bristol Foot Score), quality of life (Audit of Diabetes Dependent Quality of Life). We also assessed cost of supply and fitting. Analysis was by intention-to-treat.ResultsThere were no differences between insoles in peak pressure, or three of the other four kinetic measures. The custom-made functional insole was slightly more effective than the prefabricated insole in reducing forefoot pressure time integral at issue (27% vs. 22%), remained more effective at six month follow-up (30% vs. 24%, p=0.001), but was more expensive (UK £656 vs. £554, p<0.001). Full compliance (minimum wear 7 hours a day 7 days per week) was reported by 40% of participants and 76% of participants reported a minimum wear of 5 hours a day 5 days per week. There was no difference in patient perception between insoles.ConclusionThe custom-made insoles are more expensive than prefabricated insoles evaluated in this trial and no better in reducing peak pressure. We recommend that where clinically appropriate, the more cost effective prefabricated insole should be considered for use by patients with diabetes and neuropathy.Trial registrationClinical trials.gov (NCT00999635). Note: this trial was registered on completion.

Project description:AimsElevated dynamic plantar pressures are a consistent finding in diabetes patients with peripheral neuropathy with implications for plantar foot ulceration. This meta-analysis aimed to compare the plantar pressures of diabetes patients that had peripheral neuropathy and those with neuropathy with active or previous foot ulcers.MethodsPublished articles were identified from Medline via OVID, CINAHL, SCOPUS, INFORMIT, Cochrane Central EMBASE via OVID and Web of Science via ISI Web of Knowledge bibliographic databases. Observational studies reporting barefoot dynamic plantar pressure in adults with diabetic peripheral neuropathy, where at least one group had a history of plantar foot ulcers were included. Interventional studies, shod plantar pressure studies and studies not published in English were excluded. Overall mean peak plantar pressure (MPP) and pressure time integral (PTI) were primary outcomes. The six secondary outcomes were MPP and PTI at the rear foot, mid foot and fore foot. The protocol of the meta-analysis was published with PROPSERO, (registration number CRD42013004310).ResultsEight observational studies were included. Overall MPP and PTI were greater in diabetic peripheral neuropathy patients with foot ulceration compared to those without ulceration (standardised mean difference 0.551, 95% CI 0.290-0.811, p<0.001; and 0.762, 95% CI 0.303-1.221, p = 0.001, respectively). Sub-group analyses demonstrated no significant difference in MPP for those with neuropathy with active ulceration compared to those without ulcers. A significant difference in MPP was found for those with neuropathy with a past history of ulceration compared to those without ulcers; (0.467, 95% CI 0.181- 0.753, p = 0.001). Statistical heterogeneity between studies was moderate.ConclusionsPlantar pressures appear to be significantly higher in patients with diabetic peripheral neuropathy with a history of foot ulceration compared to those with diabetic neuropathy without a history of ulceration. More homogenous data is needed to confirm these findings.

Project description:BackgroundElevated plantar pressures represent a significant risk factor for neuropathic diabetic foot (NDF) ulceration. Foot offloading, through custom-made insoles, is essential for prevention and healing of NDF ulcerations. Objective quantitative evaluation to design custom-made insoles is not a standard method. Aims: 1) to develop a novel quantitative-statistical framework (QSF) for the evaluation and design of the insoles' offloading performance through in-shoe pressure measurement; 2) to compare the pressure-relieving efficiency of traditional shape-based total contact customised insoles (TCCI) with a novel CAD-CAM approach by the QSF.MethodsWe recruited 30 neuropathic diabetic patients in cross-sectional study design. The risk-regions of interest (R-ROIs) and their areas with in-shoe peak pressure statistically ≥200kPa were identified for each patients' foot as determined on the average of peak pressure maps ascertained per each stance phase. Repeated measures Friedman test compared R-ROIs' areas in three different walking condition: flat insole (FI); TCCI and CAD-CAM insoles.ResultsAs compared with FI (20.6±12.9 cm2), both the TCCI (7±8.7 cm2) and the CAD-CAM (5.5±7.3 cm2) approaches provided a reduction of R-ROIs mean areas (p<0.0001). The CAD-CAM approach performed better than the TCCI with a mean pressure reduction of 37.3 kPa (15.6%) vs FI.ConclusionsThe CAD-CAM strategy achieves better offloading performance than the traditional shape-only based approach. The introduced QSF provides a more rigorous method to the direct 200kPa cut-off approach outlined in the literature. It provides a statistically sound methodology to evaluate the offloading insoles design and subsequent monitoring steps. QSF allows the analysis of the whole foot's plantar surface, independently from a predetermined anatomical identification/masking. QSF can provide a detailed description about how and where custom-made insole redistributes the underfoot pressure respect to the FI. Thus, its usefulness extends to the design step, helping to guide the modifications necessary to achieve optimal offloading insole performances.

Project description:Research Question: Previous cross-sectional studies have shown an association between sudomotor dysfunction and diabetic foot ulceration (DFU). The aim of this prospective multicenter study was to determine the role of dryness of foot skin and of established neurological modalities in the prediction of risk for foot ulceration in a cohort of individuals with diabetes mellitus (DM). Design: The study was conducted from 2012 to 2017. A total of 308 subjects with DM without history of DFU or critical limb ischemia completed the study. Diabetic neuropathy was assessed using the neuropathy symptom score (NSS) and neuropathy disability score (NDS). In a subset of participants, vibration perception threshold (VPT) was evaluated. Dryness of foot skin was assessed by the visual indicator plaster method (IPM). The diagnostic performance of the above neurological modalities for prediction of DFU was tested by receiver operating characteristic curve (ROC) analysis. Results: During the 6-year follow-up, 55 patients (annual ulceration incidence 2.97%) developed DFU. Multivariate Cox-regression analysis after controlling for the effect of age, gender, and DM duration demonstrated that the risk (hazard ratio, 95% confidence intervals) of DFU increased significantly with either abnormal IPM (3.319, 1.460-7.545, p = 0.004) or high (≥6) NDS (2.782, 1.546-5.007, p = 0.001) or high (≥25 volts) VPT (2.587, 1.277-5.242, p = 0.008). ROC analysis showed that all neurological modalities could discriminate participants who developed DFU (p < 0.001). IPM testing showed high sensitivity (0.86) and low specificity (0.49), while high vs. low NDS and VPT showed low sensitivity (0.40 and 0.39, respectively) and high specificity (0.87 and 0.89, respectively) for identification of patients at risk for DFU. Conclusion: Dryness of foot skin assessed by the IPM predicts the development of DFU. IPM testing has high sensitivity, whereas high NDS and VPT have high specificity in identifying subjects at risk for DFU. The IPM can be included in the screening methods for identification of the foot at risk.

Project description:BACKGROUND:Diabetes mellitus is a major global health issue with a growing prevalence. In this context, the number of diabetic complications is also on the rise, such as diabetic foot ulcers (DFU), which are closely linked to the risk of lower extremity amputation (LEA). Statistical prediction tools may support clinicians to initiate early tertiary LEA prevention for DFU patients. Thus, we designed Bayesian prediction models, as they produce transparent decision rules, quantify uncertainty intuitively and acknowledge prior available scientific knowledge. METHOD:A logistic regression using observational collected according to the standardised PEDIS classification was utilised to compute the six-month amputation risk of DFU patients for two types of LEA: 1.) any-amputation and 2.) major-amputation. Being able to incorporate information which is available before the analysis, the Bayesian models were fitted following a twofold strategy. First, the designed prediction models waive the available information and, second, we incorporated the a priori available scientific knowledge into our models. Then, we evaluated each model with respect to the effect of the predictors and validity of the models. Next, we compared the performance of both models with respect to the incorporation of prior knowledge. RESULTS:This study included 237 patients. The mean age was 65.9 (SD 12.3), and 83.5% were male. Concerning the outcome, 31.6% underwent any- and 12.2% underwent a major-amputation procedure. The risk factors of perfusion, ulcer extent and depth revealed an impact on the outcomes, whereas the infection status and sensation did not. The major-amputation model using prior information outperformed the uninformed counterpart (AUC 0.765 vs AUC 0.790, Cohen's d 2.21). In contrast, the models predicting any-amputation performed similarly (0.793 vs 0.790, Cohen's d 0.22). CONCLUSIONS:Both of the Bayesian amputation risk models showed acceptable prognostic values, and the major-amputation model benefitted from incorporating a priori information from a previous study. Thus, PEDIS serves as a valid foundation for a clinical decision support tool for the prediction of the amputation risk in DFU patients. Furthermore, we demonstrated the use of the available prior scientific information within a Bayesian framework to establish chains of knowledge.

Dataset Information

Study protocol for a randomized controlled trial to test for preventive effects of diabetic foot ulceration by telemedicine that includes sensor-equipped insoles combined with photo documentation.

Publications

Study protocol for a randomized controlled trial to test for preventive effects of diabetic foot ulceration by telemedicine that includes sensor-equipped insoles combined with photo documentation.

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