Evidence map›Paper›PMID 28627227›Full record

Trial reportJournal of diabetes science and technology2017

Smarter Sole Survival: Will Neuropathic Patients at High Risk for Ulceration Use a Smart Insole-Based Foot Protection System?

Bijan Najafi, Eyal Ron, Ana Enriquez, Ivan Marin, Javad Razjouyan, David G Armstrong

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes science and technology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  14. Static and dynamic optimisation of fluid-filled responsive orthotic insoles.Biomechanics and modeling in mechanobiology · 2025
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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

6 authors.

Bijan Najafi1 Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA.
Eyal Ron1 Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA.
Ana Enriquez1 Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA.
Ivan Marin1 Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA.
Javad Razjouyan1 Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA.
David G Armstrong1 Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study examined adherence to alert-based cues for plantar pressure offloading in patients with diabetic foot disease. METHOD AND

designParticipants (n = 17) with in diabetic foot remission (history of neuropathic ulceration) were instructed to wear a smart insole system (the SurroSense Rx, Orpyx Medical Technologies Inc, Calgary, Canada) over a three-month period. This device is designed to cue offloading to manage unprotected sustained plantar pressures in an effort to prevent foot ulceration. A successful response to an alert was defined as pressure offloading, which occurred within 20 minutes of the alert onset. Patient adherence, defined as daily hours of device wear, was determined using sensor data and patient questionnaires. Changes in these parameters were assessed monthly.

resultsPatients demonstrating increased adherence over the course of the study received more alerts (0.82 ± 0.31 alerts/hour) than patients whose adherence did not improve (0.36 ± 0.46 alerts/hour, P = .156). By the final stages of the study, participants who had received at least one alert every two hours were more adherent with offloading than participants who received fewer alerts (52.5 ± 4.1% vs 24.7 ± 22.4%, P = .043). Furthermore, duration of time from alert generation to successful offloading was significantly greater in the group receiving fewer alerts. This was measured in the third month with an effect size Cohen's d = 1.739, P = .043.

conclusionThe results suggest a minimum number of alerts (one every two hours) is required for patients with diabetic neuropathy to optimally respond to offloading cues from a smart insole system.

Indexed as

Computers, HandheldWearable Electronic DevicesCohort StudiesDiabetic FootFemaleFootHumansMalePatient CompliancePressureProspective StudiesProtective Devicesadherencediabetic foot ulceroffloadingOrpyxphysical activity monitoringSurroSense Rxwearable sensorswound healing

Identifiers

PMID28627227
PMCPMC5588829

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.