A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial

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Abstract

Background

Neuropathic 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.

Method

A 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.

Results

There 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.

Conclusion

The 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 registration

Clinical trials.gov (NCT00999635). Note: this trial was registered on completion.

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Most cited references 45

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Simple screening tests for peripheral neuropathy in the diabetes clinic.

Zane Perkins, B Zinman, D Olaleye … (2001)

The utility of rapid and reliable sensory tests appropriate for the diagnosis of neuropathy in the diabetes clinic, rather than as prognostic tools for the prediction of foot complications, has been unclear because of limitations inherent in previous studies. Although clinical practice guidelines recommend annual screening for neuropathy, they are unable to support specific recommendations for screening maneuvers because of a lack of evidence for the validity of screening tests in the medical literature. The objective of this study was to assess the operating characteristics of four simple sensory screening maneuvers as compared with standardized electrophysiological tests in the diagnosis of distal symmetrical polyneuropathy. We assessed four simple tests (the 10-g Semmes-Weinstein monofilament examination [SWME], superficial pain sensation, vibration testing by the on-off method, and vibration testing by the timed method) in 478 subjects with independent blinded evaluations compared against the criterion standard of nerve conduction studies. We present receiver-operating characteristic (ROC) curves, positive and negative likelihood ratios, and sensitivity and specificity values for each test. The four simple screening maneuvers reveal similar operating characteristics. Cutoff points by ROC curve analyses reveal that a positive or abnormal test is represented by five incorrect responses of eight stimuli applied. A negative or normal test is represented by one or fewer incorrect responses of eight stimuli applied. By these criteria, the point estimates of the positive likelihood ratios for vibration testing by the on-off method, vibration testing by the timed method, the SWME, and superficial pain sensation test are 26.6, 18.5, 10.2, and 9.2, respectively. The point estimates of the negative likelihood ratios are 0.33, 0.51, 0.34, and 0.50, respectively The screening tests showed comparable sensitivity and specificity results. The 10-g SWME, superficial pain test, and vibration testing by the on-off method are rapid, each requiring approximately 60 s to administer. The timed vibration test takes longer, and the interpretation is more complicated. The combination of two simple tests (e.g., the 10-g SWME and vibration testing by the on-off method) does not add value to each individual screening test. Annual screening for diabetic neuropathy should be conducted using superficial pain sensation testing, SWME, or vibration testing by the on-off method. The reported operating characteristics for each sensory modality can be applied to positive findings on the physical examination of individual patients to predict the likelihood of neuropathy.

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The Foot Posture Index: Rasch analysis of a novel, foot-specific outcome measure.

Anne-Maree Keenan, Mike Horton, Anthony C. Redmond … (2006)

To investigate the internal construct validity of a clinician-assessed measure of foot position, the Foot Posture Index (FPI), versions FPI-8 and FPI-6. Rasch analysis of baseline FPI scores from studies conducted during the development of the instrument. A community-based and a hospital-based study, conducted at 2 institutions. Measures were obtained from 143 participants (98 men, 45 women; age range, 8-65y). Not applicable. Rasch analysis was undertaken using RUMM2020 software in order to evaluate the following properties of the FPI: unidimensionality of each item included in the FPI, the differential item functioning (DIF) of each item, and item and person separation indices. In the developmental draft of the instrument, the 8-item FPI-8 showed some misfit to the Rasch model (chi(16)(2) test=27.63, P=.03), indicating lack of unidimensionality. Two items were identified as problematic in the Rasch modeling: Achilles' tendon insertion (Helbing's sign), which showed illogical response ordering and "congruence of the lateral border of the foot," which showed misfit, indicating that this item may be measuring a different construct (chi(2)(2) test=15.35, P<.01). All FPI-8 items showed an absence of DIF, and the person separation index (PSI) was good (PSI=.88). The revised FPI-6, which does not include the 2 problematic items, showed unidimensionality (chi(12)(2) test=11.49, P=.49), indicating a good overall fit to the model, and improvement over the preliminary version. With the removal of the 2 problematic items, there were no disordered thresholds; all items remained DIF free and all individual items displayed a good fit to the model. The person-separation index for the FPI was similar for both the 8-item (FPI-8=.880) and 6-item (FPI-6=.884) versions. The original FPI-8 showed significant mismatching to the model. The 2 items in the FPI-8 that were identified as problematic in clinical validation studies were also found to be contributing to the lack of fit to the Rasch model. The finalized 6-item instrument showed good metric properties, including good individual item fit and good overall fit to the model, along with a lack of differential item functioning. This analysis provides further evidence for the validity of the FPI-6 as a clinical instrument for use in screening studies and shows that it has the potential to be analyzed using parametric strategies.

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Predictive value of foot pressure assessment as part of a population-based diabetes disease management program.

Andrew J M Boulton, Nicola J. Armstrong, Lawrence A. Lavery … (2003)

To evaluate the effectiveness of dynamic plantar pressure assessment to determine patients at high risk for neuropathic ulceration. In choosing the cut point, we looked for an optimum combination of sensitivity and specificity of plantar pressure to screen for neuropathic ulceration. A total of 1,666 consecutive individuals with diabetes (50.3% male) presenting to a large urban managed care-based outpatient clinic were enrolled in this longitudinal 2-year outcome study. Patients received a standardized medical and musculoskeletal assessment at the time of enrollment, including evaluation in an onsite gait laboratory. Of the entire population, 263 patients (15.8%) either presented with or developed an ulcer during the 24-month follow-up period. As expected, baseline peak plantar pressure was significantly higher in the ulcerated group than in the group who did not ulcerate (95.5 +/- 26.4 vs. 85.1 +/- 27.3 N/cm(2), P < 0.001). There was also a trend toward increased pressure with increasing numbers of foot deformities, as well as with increasing foot risk classification (P = 0.0001). Peak pressure was not a suitable diagnostic tool by itself to identify high-risk patients. After eliminating patients without loss of protective sensation, using receiver operating characteristic (ROC) analysis, the optimal cut point, as determined by a balance of sensitivity and specificity, was 87.5 N/cm(2), yielding a sensitivity of 63.5% and a specificity of 46.3%. The data from this evaluation continue to support the notion that elevated foot pressure is an important risk factor for foot complications. However, the ROC analysis suggests that foot pressure is a poor tool by itself to predict foot ulcers.

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Author and article information

Journal

Journal ID (nlm-ta): J Foot Ankle Res

Journal ID (iso-abbrev): J Foot Ankle Res

Title: Journal of Foot and Ankle Research

Publisher: BioMed Central

ISSN (Electronic): 1757-1146

Publication date Collection: 2012

Publication date (Electronic): 5 December 2012

Volume: 5

Page: 31

Affiliations

[1 ]Faculty of Health, Education and Society, Plymouth University, Plymouth, UK

[2 ]Plymouth Community Health Care (CIC), Plymouth, UK

[3 ]Faculty of Science and Technology, Plymouth University, Plymouth, UK

Article

Publisher ID: 1757-1146-5-31

DOI: 10.1186/1757-1146-5-31

PMC ID: 3554426

PubMed ID: 23216959

SO-VID: 0b3258d9-bc80-4832-8779-9ef03a4187c9

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial

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Most cited references 45

Simple screening tests for peripheral neuropathy in the diabetes clinic.

The Foot Posture Index: Rasch analysis of a novel, foot-specific outcome measure.

Predictive value of foot pressure assessment as part of a population-based diabetes disease management program.

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