Evidence map›Paper›PMID 24760263›Full record

Trial reportDiabetes care2014

Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial.

Jan S Ulbrecht, Timothy Hurley, David T Mauger, Peter R Cavanagh

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 13 pooled it
8.6field-weighted citation impact, top 2% 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.

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

56 citing papers in PubMed, 13 syntheses or guidelines pooled it, 181 citations in OpenAlex.

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  15. Geometric Feature Relationship-Based Knowledge Distillation for Ground Reaction Force Estimation.Measurement : journal of the International Measurement Confederation · 2026
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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

4 authors at 3 institutions in 1 country.

Jan S UlbrechtDepartment of BioBehavioral Health, Pennsylvania State University, University Park, PADepartment of Medicine, Pennsylvania State University, State College, PAMount Nittany Health System, State College, PADIApedia LLC, State College, PA.
Timothy HurleyDIApedia LLC, State College, PA.
David T MaugerDepartment of Public Health Sciences, Pennsylvania State University, Hershey, PA.
Peter R CavanaghDIApedia LLC, State College, PADepartment of Orthopaedics and Sports Medicine, University of Washington, Seattle, WA cavanagh@u.washington.edu.
Pennsylvania State University · USDIApedia (United States) · USUniversity of Washington · US

Funding

CAD-CAM Technology for Diabetic FootwearR44DK059074 · NIDDK · DIAPEDIA, LLC · PI LOOMIS, JOSEPH L · 2003 to 2010
$4.5M
NIDDK NIH HHS 2R44-DK-059074NIDDK NIH HHS R44 DK059074
6 · The paper itself

Abstract

objectiveTo assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration. RESEARCH DESIGN AND

methodsSingle-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion) or to study termination. Proportional hazards regression was used for analysis.

resultsThere was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3-8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study.

conclusionsWe conclude that shape- and barefoot plantar pressure-based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses, but they did not significantly reduce nonulcerative lesions.

Indexed as

Orthotic DevicesAdultAgedAged, 80 and overDiabetes MellitusDiabetic FootFemaleFollow-Up StudiesFootFoot UlcerHumansMaleMiddle AgedPeripheral Nervous System DiseasesPressureSecondary Prevention

Identifiers

PMID24760263
PMCPMC4067390
OpenAlexW2152680533

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.