Evidence map›Paper›PMID 37705016›Full record

Observational studyJournal of foot and ankle research2023

Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study.

Stein H Exterkate, Manon Jongebloed-Westra, Peter M Ten Klooster, Hendrik Koffijberg, Christina Bode, Julia E W C van Gemert-Pijnen, Josephus G van Baal, Jaap J van Netten

Registry-linked trialOpen access · goldAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of foot and ankle research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07488104 (Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07488104 narecruitingnot on this mapstarted 2026, after this paper: background citation

Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy

TypeinterventionalSponsorUniversity Medical Center GroningenRan2026 to 2027Enrolled30ConditionsDiabetic NeuropathyArmsLEEF-shoe, standard orthopaedic shoe
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

Stein H ExterkateResearch & Development, Voetencentrum Wender, Hengelo, 7555 SK, The Netherlands. s.exterkate@podotherapeut.nl.ORCID http://orcid.org/0009-0004-0538-4370
Manon Jongebloed-WestraDepartment of Psychology, Health and Technology, Centre for eHealth Research and Wellbeing, University of Twente, Enschede, 7500 AE, The Netherlands.
Peter M Ten KloosterDepartment of Psychology, Health and Technology, Centre for eHealth Research and Wellbeing, University of Twente, Enschede, 7500 AE, The Netherlands.
Hendrik KoffijbergDepartment of Health Technology and Services Research, Tech Med Centre, University of Twente, Enschede, 7500 AE, The Netherlands.
Christina BodeDepartment of Psychology, Health and Technology, Centre for eHealth Research and Wellbeing, University of Twente, Enschede, 7500 AE, The Netherlands.
Julia E W C van Gemert-PijnenDepartment of Psychology, Health and Technology, Centre for eHealth Research and Wellbeing, University of Twente, Enschede, 7500 AE, The Netherlands.
Josephus G van BaalResearch & Development, Voetencentrum Wender, Hengelo, 7555 SK, The Netherlands.
Jaap J van NettenDepartment of Rehabilitation Medicine, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, the Netherlands.ORCID http://orcid.org/0000-0002-6420-6046
University of Twente · NLAmsterdam University Medical Centers · NLZiekenhuis Groep Twente · NL

Funding

ZonMw 853001101
6 · The paper itself

Abstract

backgroundOrthopaedic footwear can only be effective in preventing diabetic foot ulcers if worn by the patient. Robust data on long-term wearing time of orthopaedic footwear are not available, and needed to gain more insights into wearing patterns and associated factors (i.e. participants' demographic, disease-related characteristics, and footwear usability). We aimed to objectively assess long-term wearing patterns and identify factors associated with wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of ulceration.

methodsPeople diagnosed with diabetes mellitus type 1 and 2 with loss of protective sensation and/or peripheral artery disease and prescribed with orthopaedic footwear were included and followed for 12 months. The primary outcome was mean daily wearing time, continuously measured using a temperature sensor inside the footwear (Orthotimer®). Adherence to wearing orthopaedic footwear was calculated as percentage of wearing time of a total assumed 16 h out-of-bed daytime, where adherence < 60% was a pre-determined non-adherent threshold. Wearing time patterns were assessed by calculating participants' wearing (in)consistency. One-way analyses of variance tested for wearing time differences between subgroups, weekdays, and weekend days. Factors potentially associated with wearing time were collected by questionnaires and medical files. Univariately associated factors were included in multivariate linear regression analysis.

resultsSixty one participants were included (mean (SD) age: 68.0 (7.4) years; females: n = 17; type 2 diabetes mellitus: n = 54). Mean (SD) overall daily wearing time was 8.3 (6.1) hours/day. A total of 40 (66%) participants were non-adherent. Participants with a consistent wearing pattern showed higher daily wearing times than participants with an inconsistent pattern. Mean (SD) wearing times were 12.7 (4.3) vs 3.6 (4.8) hours/day, respectively (P < 0.001). Mean (SD) wearing time was significantly higher (P < 0.010) during weekdays (8.7 (6.0) hours/day) compared to Saturday (8.0 (6.1) hours/day) and Sunday (6.9 (6.2) hours/day). In the multivariate model (R

conclusionsOnly one out of three people at moderate to high risk of foot ulceration were sufficiently adherent to wearing their orthopaedic footwear. Changing people's wearing behaviour to a more stable pattern seems a potential avenue to improve long-term adherence to wearing orthopaedic footwear. Investigated factors are not associated with daily wearing time. Based on these factors the daily wearing time cannot be estimated in daily practice.

trial registrationNetherlands Trial Register NL7710. Registered: 6 May 2019.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic FootOrthopedicsAgedFemaleHumansLinear ModelsDiabetes mellitusDiabetic footOrthopaedic footwearTreatment adherence and complianceWearing time

Identifiers

PMID37705016
PMCPMC10500813
OpenAlexW4386726455

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.