Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study

Abstract Background: Therapeutic footwear and insoles are preventative strategies to reduce elevated plantar pressures associated with diabetic foot ulcer risk. An insole intervention appropriate for chairside delivery optimizing plantar foot pressure reduction in people with diabetes has been developed. Aim: To explore the feasibility and acceptability of testing an optimized insole compared with an active control insole to reduce plantar pressures for people with diabetic peripheral neuropathy.Methods: A double-blinded multicentre feasibility RCT with an embedded qualitative study. In addition to usual care, participants were randomized to either an optimized insole group (Intervention) or a standard cushioned insole group (Active control). Participants were assessed at baseline, 3, 6 and 12 months with clinical outcome of mean peak plantar pressure (MPPP) reduction. An embedded qualitative study involved semi-structured interviews with 12 study participants and three podiatrists to explore their experiences of the intervention and trial procedures. Data were analyzed using descriptive statistics (quantitative data) and thematic analysis (qualitative data).Results: Screened were142 patients from which 61 were recruited; 30 participants were randomized to the Intervention group and 31 to the Active control group. Forty-two participants completed the study. At 12-months, 69% of the patient-reported questionnaires were returned and 68% of the clinical outcomes were collected. Mean difference in MPPP between the Intervention and Active control groups for all regions-of-interest combined favoured the Intervention, with increases from 87kPa at post-randomization to 255kPa at 12-months. Thematic analysis revealed three themes; accepting the study, behaviour and support during study procedures, and impact from study participation. Conclusion: The results of the feasibility RCT suggest that the optimized insole holds promise as an intervention, and that a full RCT to evaluate the clinical and cost-effectiveness of this intervention is feasible and warranted for people with diabetic peripheral neuropathy. Trial registration: International Standard Randomized Controlled Trial Number: ISRCTN16011830. Registered 9th October 2017, https://www.isrctn.com/ISRCTN16011830

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Plantar Pressure Distribution in Patients with Diabetic Peripheral Neuropathy and a First-Ray Amputation

Journal of the American Podiatric Medical Association ◽

10.7547/16-021 ◽

2018 ◽

Vol 108 (3) ◽

pp. 225-230 ◽

Cited By ~ 2

Author(s):

Iona Borg ◽

Stephen Mizzi ◽

Cynthia Formosa

Keyword(s):

Peripheral Neuropathy ◽

Plantar Pressure ◽

Diabetic Peripheral Neuropathy ◽

Metatarsophalangeal Joint ◽

Plantar Pressures ◽

Plantar Pressure Distribution ◽

Pressure Time ◽

First Ray ◽

Metatarsophalangeal Joints ◽

Ray Amputation

Background: Elevated dynamic plantar pressures are a consistent finding in diabetic patients with peripheral neuropathy, with implications for plantar foot ulceration. This study aimed to investigate whether a first-ray amputation affects plantar pressures and plantar pressure distribution patterns in individuals living with diabetes and peripheral neuropathy. Methods: A nonexperimental matched-subject design was conducted. Twenty patients living with diabetes and peripheral neuropathy were recruited. Group 1 (n = 10) had a first-ray amputation and group 2 (n = 10) had an intact foot with no history of ulceration. Plantar foot pressures and pressure-time integrals were measured under the second to fourth metatarsophalangeal joints, fifth metatarsophalangeal joint, and heel using a pressure platform. Results: Peak plantar pressures under the second to fourth metatarsophalangeal joints were significantly higher in participants with a first-ray amputation (P = .008). However, differences under the fifth metatarsophalangeal joint (P = .734) and heel (P = .273) were nonsignificant. Pressure-time integrals were significantly higher under the second to fourth metatarsophalangeal joints in participants with a first-ray amputation (P = .016) and in the heel in the control group (P = .046). Conclusions: Plantar pressures and pressure-time integrals seem to be significantly higher in patients with diabetic peripheral neuropathy and a first-ray amputation compared with those with diabetic neuropathy and an intact foot. Routine plantar pressure screening, orthotic prescription, and education should be recommended in patients with a first-ray amputation.

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Effects of offloading devices on static and dynamic balance in patients with diabetic peripheral neuropathy: A systematic review

Reviews in Endocrine and Metabolic Disorders ◽

10.1007/s11154-020-09619-9 ◽

2021 ◽

Author(s):

Koen Andre Horstink ◽

Lucas Henricus Vincentius van der Woude ◽

Juha Markus Hijmans

Keyword(s):

Systematic Review ◽

Peripheral Neuropathy ◽

Plantar Pressure ◽

Diabetic Peripheral Neuropathy ◽

Balance Control ◽

Dynamic Balance ◽

Movement Control ◽

Future Research ◽

Static Balance ◽

Somatosensory Information

AbstractPatients with diabetic peripheral neuropathy (DPN) usually have reduced somatosensory information and altered perception in feet and ankles. Somatosensory information acts as feedback for movement control and loss of somatosensation leads to altered plantar pressure patterns during gait and stance. Offloading devices are used to reduce peak plantar pressure and prevent diabetic foot ulcers. However, offloading devices can unfortunately have negative effects on static and dynamic balance. It is important to investigate these unwanted effects, since patient with DPN already are at high risk of falling and offloading devices could potentially increase this risk. The aim of this systematic review is to investigate the effects of plantar offloading devices used for ulcer prevention on their role in static and dynamic balance control in patients with DPN. PubMed and Embase were systematically searched using relevant search terms. After title selection, abstract selection, and full-text selection only five articles could be included for further analysis. Two articles included static balance measurements, two articles included dynamic balance measurements, and one article included both. Results suggested that static balance control is reduced when rocker bottom shoes and different insole configurations are used, however, toe-only rockers showed less evidence for reduced static balance control. There was no evidence for reduced dynamic balance control in combination with offloading devices. However, these results should be interpreted with care, since the number of studies was very small and the quality of the studies was moderate. Future research should evaluate balance in combination with different offloading devices, so that clinicians subscribing them are more aware of their potential unwanted consequences.

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