Effectiveness of insoles used for the prevention of ulceration in the neuropathic diabetic foot: a systematic review

Article Outline

• Abstract
• 1. Background
• 2. Aim
• 3. Review methods
• 4. Data sources and search strategy
  • 4.1. Study selection
  • 4.2. Study quality assessment
  • 4.3. Data extraction
• 5. Details of included studies
  • 5.1. Clinical setting of the studies
• 6. Methodological quality
• 7. Results of the review
  • 7.1. Prevention of ulceration
  • 7.2. Reduction of peak pressure
  • 7.3. Patient-based response
  • 7.4. Cost effectiveness
• 8. Discussion
• 9. Conclusion
• References
• Copyright

Abstract 

Context

Ulceration can be a debilitating and costly complication of the neuropathic diabetic foot. Insoles inserted into footwear are routinely used in clinical practice to help to prevent ulceration.

Aim and Scope of the Review

This review evaluated the effectiveness of insoles used for the prevention of ulcer in the neuropathic diabetic foot.

Methods

Databases were searched from inception to 2008, supplemented by hand searching of references and grey literature. Data extraction and methodological quality assessment were independently conducted by two reviewers following the recommendations of the Centre for Reviews and Dissemination.

Results

A total of five trials met the inclusion criteria: two randomised control trials (RCTs), two case control studies, and one follow-up study. The methodological quality of the majority of studies was poor. Omitted details regarding the generalisability of results made study comparison and inference to practice difficult. There is a small amount of limited evidence indicating that insoles are effective in reducing incidence of ulceration and reducing plantar peak pressures in the diabetic neuropathic foot. No study included economic analysis or patient-based outcome measures.

Conclusions

Insoles appear of use for the prevention of neuropathic diabetic foot ulceration, although evidence is limited. Clinical recommendation regarding type and specification of insole is not possible at this time.

There is an essential need for a large well-designed RCT comparing different types of commonly used insole for the prevention of ulceration in the diabetic neuropathic foot. Outcome measures should include patient perceptions of the effectiveness and cost-effectiveness analysis.

Keywords: Insoles, Ulceration, Neuropathic diabetic foot

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1. Background 

Foot ulceration can be debilitating for people with diabetes and has been found to precede 84% of lower extremity amputations (Pecoraro, Reiber, & Burgess, 1990). The estimated total annual cost of diabetes-related foot complications in the UK is approximately £252 million, inclusive of £8459 for every single amputation (Gordois, Scuffham, Shearer, Ogelsby, & Tobian, 2003). The greater cost, however, is burdened by the patient and their family; the reported survival rate from major amputation is less than 50%, 5 years postoperatively (Papazafiropoulou et al., 2008). Preventing diabetic foot ulceration is therefore crucial to reducing the incidence of amputation (Fryberg et al., 1998). The aetiology of this condition is complex and multifactorial, demanding a multifaceted management approach for successful wound prevention and treatment (Dang & Boulton, 2003, Millington & Norris, 2000, Muha, 1999). In areas where a multifaceted approach has been implemented, amputation rates have lowered (Conner, 1997, Edmonds et al., 1986, Frykberg et al., 2002). The provision of insoles and therapeutic footwear is an important element of the prevention strategy within these multifaceted foot clinics (Frykberg et al., 2002).

Neuropathy affects more than 50% of people with type 2 diabetes mellitus over 60 years of age (Young, Veves, & Boulton, 1993) contributing to the onset of 85% of diabetic foot ulcers (Boulton, 1996). High plantar pressures associated with the neuropathic foot increase the risk of foot ulcer development (Caselli et al., 2002, Sauseng et al., 1999, Stess et al., 1997, Veves et al., 1992). Insoles designed to reduce elevated plantar pressure are currently prescribed to help prevent ulceration (Spencer, 2000). However, the clinical effectiveness of insoles commonly prescribed for neuropathic diabetic foot ulcer prevention is yet to be proven.

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2. Aim 

The aim of this review was to evaluate the effectiveness of insoles used for the prevention of ulcer in neuropathic diabetic foot.

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3. Review methods 

A systematic review of the literature was undertaken and reported, based upon the NHS Centre for Reviews and Dissemination guidance for the carrying out, reporting, or commissioning of reviews (Khan, ter Riet, Glanville, Sowden, & Kleijnen, 2001).

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4. Data sources and search strategy 

Electronic databases MEDLINE and CINAHL were systematically searched for potentially relevant citations. A further search of the grey literature including government documents and a thesis database (http://www.thesis.com) was conducted. Reference lists of publications (primary studies and reviews) were scanned for further potential relevant citations. Relevant studies were identified using the search terms and groups of terms shown in Table 1.

Table 1. Search terms relevant to the effectiveness of insoles used for the prevention of ulceration in the neuropathic diabetic foot

All citations, abstracts, and papers were independently scanned by two investigators (JP and ES). The initial broad search produced 498 papers including 174 duplications. Screening by title of the remaining 324 citations retrieved 92 abstracts; from this, a further scan identified 30 potentially relevant articles (Table 2). A total of five papers meeting the inclusion criteria were included into the review. Fig. 1 contains a flow chart documenting study selection. Disagreement regarding inclusion occurred for 10 studies; judgment was resolved through discussion. A 97% rate of agreement was recorded between assessors; the decision process appeared reliable and decisions reproducible.

Table 2. List of full text articles obtained: effectiveness of insoles used for the prevention of ulceration in the neuropathic diabetic foot

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• Fig. 1. 

  Flow diagram of the study selection process.

4.1. Study selection 

Studies were selected for inclusion into the review based on the following criteria:

Randomised control trials (RCTs) are regarded as most the most powerful study design for measuring intervention effectiveness. However, a recent systematic Cochrane review of the literature discovered that the few RCTs investigating the prevention and treatment of diabetic foot ulcers were of poor quality. To gain new additional information, this systematic review was expanded to include longitudinal studies ranked lower on the hierarchy of study design.

This systematic review was interested in the prevention of ulceration; therefore data incorporating persons with current ulceration and requiring treatment was excluded.

The pathway to neuropathic ulceration is believed to differ from that of ischemic ulceration. The literature suggests that insoles are specific in addressing factors associated predominantly with neuropathic ulceration, for example, reducing peak pressure. Therefore this review only considered data collected from persons diagnosed with neuropathy.

The primary outcome measure of interest was time to ulceration. However, practical and resource limitations imposed on most studies result in the substitution of intermediate term outcome measures such as pressure measurement. Other aspects of effectiveness offer valuable information to clinicians and policymakers comparing similar interventions; including cost and patient perception.

This systematic review focuses on the effectiveness of insoles in the prevention of diabetic foot ulceration. Thus studies investigating other forms of preventative therapy were excluded from the review.

4.2. Study quality assessment 

Studies were classified according to level of methodological rigor using a validated quality assessment instrument (Downs & Black, 1998). The assessment instrument provided not only an overall quality score but also scored dimensions of quality, i.e., quality of reporting, internal validity (bias and confounding), and external validity. The tool offered a combined checklist for both randomised and nonrandomised studies of health care interventions.

Each study included within the review was independently evaluated by two investigators (JP and ES).

4.3. Data extraction 

Data extracted from each study was relevant and appropriate to achieving the review aim (Table 3). Data extraction was performed independently by two investigators (JP and ES).

Table 3. Characteristics of studies evaluating the effectiveness of insoles used for the prevention of ulceration in the neuropathic diabetic foot

PTI, Pressure/time integral.

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5. Details of included studies 

A total of five papers met the inclusion criteria. Two papers were RCTs, two case control studies, and one a follow-up study. Two studies investigated the effectiveness of Plastazote-based casted insoles: one assessed ulcer relapse rate (Ucciloi et al., 1995) and the other reduction in peak pressure (Mohamed et al., 2004). One trial explored the effect of an ethylene-vinyl acetate (EVA) and polyethylene foam insole on peak pressure (Lobmann et al., 2001). Another evaluated the effectiveness of magnetic insoles to reduce neuropathic pain and improve quality of life (Weintraub et al., 2003). One assessed the effect of a ridged (TL-2100 graphite) casted insole on peak pressure and contact surface area (Albert & Rinoie, 1994) (Table 3).

5.1. Clinical setting of the studies 

Three of the studies were conducted in the USA (Albert & Rinoie, 1994, Mohamed et al., 2004, Weintraub et al., 2003), one in Italy (Ucciloi et al., 1995), and one in Germany (Lobmann et al., 2001). Two trials recruited participants attending university or teaching hospitals (Ucciloi et al., 1995, Weintraub et al., 2003). One study was conducted from an orthotics laboratory (Mohamed et al., 2004). A total of 37 private practices were also used for subject recruitment for one study (Weintraub et al., 2003). The setting was not reported for two studies (Albert & Rinoie, 1994, Lobmann et al., 2001).

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6. Methodological quality 

The methodological quality of four of the studies was poor (Albert & Rinoie, 1994, Lobmann et al., 2001, Mohamed et al., 2004) and one considered good (Weintraub et al., 2003). The information reported in all studies was sufficient to assess the study outcome and included a clear description of interventions, main outcomes, and findings. Largely absent was relevant detail of adverse events (Albert & Rinoie, 1994, Lobmann et al., 2001, Mohamed et al., 2004) and characteristics of patients lost to follow-up (Albert & Rinoie, 1994, Mohamed et al., 2004, Ucciloi et al., 1995). Full details of methodological quality are tabulated in Table 4.

Table 4. Quality of study method: evaluating the effectiveness of insoles used for the prevention of ulceration in the neuropathic diabetic foot

To be useful, it is important that study results can be generalised to the larger population. Thus study subjects should represent the entire population from which they are recruited. The external validity of four studies was poor or unclear: one recruited only volunteers (Albert & Rinoie, 1994) and three published insufficient information regarding the source population (Lobmann et al., 2001, Mohamed et al., 2004, Ucciloi et al., 1995). Only one study demonstrated good external validity including some detail of the population from which the sample was drawn (Weintraub et al., 2003).

Blinding of the intervention to subjects and health care professionals occurred in just one study (Weintraub et al., 2003). Although important to prevent bias of results, no attempt to conceal the intervention was apparent in any other study.

The main outcome measures were clearly described and evidence given of accuracy and reliability in three studies (Albert & Rinoie, 1994, Mohamed et al., 2004, Weintraub et al., 2003). A clear definition of the main outcome measure, ulceration, was absent from one report (Uccioli et al., 1995), while a second gave no confirmation of the accuracy or reliability of the equipment or protocol used to record peak pressure (Lobmann et al., 2001).

Knowledge of compliance is crucial to assessing intervention effect; otherwise, it becomes unclear whether findings are representative of intervention response or diluted by noncompliance. Intervention compliance was reported in only one study (Lobmann et al., 2001).

Randomisation of intervention allocation with concealment is considered the only trusted method not to introduce bias. Just one trial comprehensively reported applying these principles to the study design (Weintraub et al., 2003). While one other mentioned randomising subjects but excluded detail of the method used (Uccioli et al., 1995).

Statistical tests of significance assume baseline comparability of confounding factors between groups. This is of particular importance in the development of diabetic foot ulceration. An imbalance of baseline factors associated with ulceration such as previous ulceration, foot deformity, or duration of diabetes means that differences found at follow-up cannot be attributed solely to the intervention. However, only one study appeared to fully consider the effect of confounding in the analysis (Uccioli et al., 1995). One study did not recruit a control group but rather made conclusions based upon findings from a single intervention group (Albert & Rinoie, 1994). One reported an imbalance in confounders but made no apparent adjustment in the analysis (Lobmann et al., 2001). A description of the distribution of important confounders between groups was absent from one publication (Mohamed et al., 2004).

Managing loss to follow-up data and deciding what patients to include in the analysis require careful planning if bias of results is to be avoided. Only one study considered number of subjects lost to follow-up (n=90) but only to conduct an as-treated analysis (Weintraub et al., 2003). Although the balance of participants lost to follow-up was equally distributed between groups, this approach risks producing an elevated treatment effect because often it is the patients with a poorer prognosis who drop out and are excluded from the analysis.

Appropriate method of statistical analysis was evident for all studies but one, where parametric methods were applied to a sample size better suited to nonparametric analysis (Albert & Rinoie, 1994). Only one study reported conducting a priori sample size analysis, recruiting sufficient participants to identify a significant difference (P=.05) between groups at a power of 80% (Weintraub et al., 2003). Sample size was deficient (n<100) in all other studies.

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7. Results of the review 

7.1. Prevention of ulceration 

Uccioli (1995) compared ulceration relapse rate in two groups of diabetic individuals over 12 months. One group was provided with insoles (PPT and Plastazote casted insoles with therapeutic shoes) and the other wore their own nontherapeutic footwear. The incidence of reulceration was significantly reduced for the group wearing insoles; 27.7% of participants in the intervention group relapsed compared to 58.3% of participants in the control group (P=.009).

7.2. Reduction of peak pressure 

Three studies investigated the effectiveness of insoles to reduce peak pressure (Lobmann et al., 2001, Mohamed et al., 2004, Ucciloi et al., 1995). One identified two sites of interest (first metatarsal head and medial heel) to compare differences in peak pressures with and without insoles for a single group of eight participants over a 3-month period (Albert & Rinoie, 1994). After 1 month, the reduction in peak pressure at the first metatarsal head with insoles was 26%, falling to 21% at 3-month follow-up (P=.001) (Albert & Rinoie, 1994).

The second study compared insoles issued to 18 high-risk people with diabetes with 63 diabetic controls using conventional footwear (Lobmann et al., 2001). An initial 25% reduction in peak pressure from baseline was recorded under the first metatarsal head with the introduction of the insole. After 1 year of use, the peak pressure at the same site in the intervention group was 6% greater than that recorded at baseline; in comparison, over the same period, peak pressures under the first metatarsal head of the control group increased by 20%. Total initial reduction in peak pressure with insole was 32.6%, reducing slightly to 28% after 6 months of wear (Lobmann et al., 2001). The number of people developing foot ulcers during the trial was not reported.

Mohamed et al. (2004) allocated 16 diabetic subjects to one of two interventions, a Plastazote insole or Aliplast and Plastazote insole. Comparison after 3 months found no difference between the two devices. The reduction in peak pressure under the area of the first metatarsal head and hallux measured at insole issue and 3-month follow-up was 28% and 29%. Similar reductions in peak pressure (32% at issue and 26% at 3 months) were recorded for the whole foot.

7.3. Patient-based response 

Only one trial recorded patient response (Weintraub et al., 2003). A multi-centred, double-blind, RCT analysed the effect of magnetic insoles on a number of patient-reported outcome measures including burning, numbness and tingling foot pain, and sleep disturbance. Patients in both the intervention and placebo control groups reported a reduction in neuropathic symptoms, with the magnetic insoles performing significantly better over 4 months (P<.05). Recorded as an adverse effect, ulceration did not occur in either group during the 4-month duration of the study.

7.4. Cost effectiveness 

No study meeting the inclusion criteria included cost-effectiveness analysis.

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8. Discussion 

Within the limitations of the current evidence, insoles are effective in reducing ulceration rate and peak pressure in people with diabetes and neuropathy.

The aetiology for neuropathic foot ulceration differs from that of ischemic ulceration. Ulceration development in the neuropathic foot is associated with changes in foot structure and function and sensory perception loss not present in the ischemic foot (Masson et al., 1989, Mueller et al., 1990). Thus insoles designed for the prevention of ulcer in the neuropathic diabetic foot may not benefit the ischemic foot. While both complications commonly present together, it is crucial to outcome that the treatment provided is appropriate to presenting pathology. Inference of the research to clinical practice would be increased if reviewers and researchers distinguished between foot pathology. Unlike other reviews, this systematic review of the literature is specific to the neuropathic diabetic population (Maciejewski et al., 2004, Mason et al., 1999, Spencer, 2000).

This review aimed to establish the effectiveness of insoles used for the prevention of ulcer in the neuropathic diabetic foot. One eligible RCT, however, failed to add to the fulfillment of this aim (Weintraub et al., 2003). This robust, high-quality study investigated the effect of magnetic insoles on neuropathic pain and quality of life, not directly related to foot ulcer prevention. The findings of this trial were not therefore considered within the context of this discussion.

Information provided by the studies included in this review was insufficient to fully determine whether the observed effect might be reflected in clinical practice. To assess applicability of findings to clinical practice, further detail is needed regarding the population from which the study sample was recruited, available staff and facilities, and concomitant treatment received by participants. Additional factors limiting generalisability of findings to practice and absent from some studies include distribution of confounding factors at baseline, level of compliance, and reporting of adverse effects. These potential influences of intervention effect are necessary to provide essential information to service providers and policymakers of diabetic foot care planning insole provision for the diabetic neuropathic foot. It is acknowledged that the poor apparent methodological quality of some studies may reflect inadequate reporting and missing information attributed in part to the manuscript word limits enforced by publishing journals.

All studies were underpowered, raising the possibility of a type 2 error increasing the chance of not reporting a difference in interventions when one exists. None of the studies reported applying a robust RCT design. It is suggested that RCTs are the most powerful research method for assessing the effectiveness of two interventions (Friedman, Furberg, & DeMets, 1989). Important elements fundamental to RCT design, including concealed randomisation and treatment allocation procedures, provide the only sure method of preventing result bias (Altman, 2001, Altman & Bland, 1999, Altman et al., 2001).

The studies included within the review were too heterogeneous to be combined for meta-analysis. Studies differed in terms of participant demographics, intervention specification, and outcomes measures. Three of the five studies included in the review recorded peak pressure data as a measure of effect (Lobmann et al., 2001, Ucciloi et al., 1995, Mohamed et al., 2004). All insoles tested reduced peak pressure under the first metatarsal head region by between 20% and 30%. Two trials reported a total initial reduction in peak pressure of 32% with insole. These findings suggest that insoles appear effective in reducing diabetic neuropathic foot pressures. However, given the limited methodological quality of the existing studies, there is a clear need for large, well-designed RCTs to provide further evidence of insole effectiveness in neuropathic foot ulcer prevention. Ulceration is associated with elevated peak pressures; therefore reducing peak pressure is an appropriate clinical aim for reducing ulceration risk (Armstrong et al., 1998, Ctercteko et al., 1981).

Insoles require frequent review and replacement to remain useful. The limited longitudinal data presented suggests insole effect may be compromised between 6 months and 1 year of wear and prior to visual insole fatigue (Albert & Rinoie, 1994, Lobmann et al., 2001, Mohamed et al., 2004, Ucciloi et al., 1995). Without further research and guidance, the frequency of insole replacement for patients with diabetic neuropathy will remain dependent upon resource availability and professional judgment.

Different types of insole are designed to function differently: some aim to increase dampening and cushion the foot or increase surface contact area to achieve pressure reduction, while others offer functional control to modify loading patterns. Scant details of insole specifications reported by authors make comparison between studies and application to clinical practice difficult. The prescription specification of the insole provided, including the materials selected for fabrication, device profile, and modification, requires a highly skilled clinician (orthotist, podiatrist). Decision regarding the type of insole appropriate to need should be based upon best evidence, a full knowledge of medical history, social status, and established following a careful examination of lower limb mechanics. Such expertise and service provision may not be readily or immediately available to all potential beneficiaries. This has resulted in an increasing range of prefabricated devices entering the market place offering an instant alternative solution. No studies were found comparing prefabricated and custom-made devices.

Although an important consideration for service providers and policymakers of clinical practice, economic analysis was not included by any study nor were patient-based outcome measures considered.

It is widely accepted that development of ulceration is complex involving factors both intrinsic and extrinsic to the foot; insole provision forms only one element of the holistic ulcer prevention strategy recommended for individuals diagnosed with diabetic neuropathy. The effect of insoles used for the prevention of ulceration in diabetic foot may be optimised if used in a shared care environment and in conjunction with other preventative therapies such as patient education, good glycaemic control, and monitoring of complication progression (Mason et al., 1999).

It is acknowledged that the exclusion questionnaire developed for study selection, although reliable, lacked the sensitivity to exclude all articles not related to the review question. However, it was considered preferable that the selection process captured one study containing discarded information rather than risk excluding important studies of relevance.

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9. Conclusion 

Insoles designed to prevent ulceration in the diabetic neuropathic foot appear to be of some value and should be considered within the prevention strategy for the diabetic neuropathic foot. Recommendation cannot be made at this time regarding the type and specification of insole best suited for purpose.

There is a need for further research investigating the following:

To add value to the evidence base, future research should comply with the requirements of a well-designed, quality RCT. Within this methodology, authors should report measures of compliance and adverse effects.

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