Evidence map›Paper›PMID 38997439›Full record

Trial reportScientific reports2024

Affordable web-based foot-ankle exercise program proves effective for diabetic foot care in a randomized controlled trial with economic evaluation.

Ronaldo H Cruvinel-Júnior, Jane S S P Ferreira, Jady L Veríssimo, Renan L Monteiro, Érica Q Silva, Eneida Y Suda, Isabel C N Sacco

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04011267 (Effect of Customized Software for Foot-related Exercises), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT04011267 nacompletednot on this map

Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-I) Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2019 to 2022Enrolled62ConditionsDiabetic NeuropathiesArmsPhysical therapy by foot-ankle segmental and functional exercises
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
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

7 authors.

Ronaldo H Cruvinel-JúniorDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
Jane S S P FerreiraDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
Jady L VeríssimoDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
Renan L MonteiroDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
Érica Q SilvaDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
Eneida Y SudaDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
Isabel C N SaccoDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil. icnsacco@usp.br.

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 28/2018 FOCA Trial 407252/2018-5Coordenação de Aperfeiçoamento de Pessoal de Nível Superior Financial Code 001Fundação de Amparo à Pesquisa do Estado de São Paulo 2017/17848-3Fundação de Amparo à Pesquisa do Estado de São Paulo 2019/02522-0Fundação de Amparo à Pesquisa do Estado de São Paulo 2021/00807-8
6 · The paper itself

Abstract

The aim of this study was to shed light on a crucial issue through a comprehensive evaluation of the cost-effectiveness and cost-utility of a cutting-edge web-based foot-ankle therapeutic exercise program (SOPeD) designed for treating modifiable risk factors for ulcer prevention in individuals with diabetes-related peripheral neuropathy (DPN). In this randomized controlled trial, 62 participants diagnosed with DPN were assigned to the SOPeD software or received usual care for diabetic foot. Primary outcomes were DPN symptoms and severity, foot pain and function, and quality-adjusted life years (QALYs). Between-group comparisons provided 95% confidence intervals. The study also calculated incremental cost-effectiveness and cost-utility ratios (ICERs), analyzed direct costs from a healthcare perspective, and performed a sensitivity analysis to assess uncertainty. The web-based intervention effectively reduced foot pain, improved foot function and showed favorable cost-effectiveness, with ICERs ranging from (USD) $5.37-$148.71 per improvement in different outcomes. There is a high likelihood of cost-effectiveness for improving DPN symptoms and severity, foot pain, and function, even when the minimum willingness-to-pay threshold was set at $1000.00 USD. However, the intervention did not prove to be cost-effective in terms of QALYs. This study reveals SOPeD's effectiveness in reducing foot pain, improving foot function, and demonstrating cost-effectiveness in enhancing functional and clinical outcomes. SOPeD stands as a potential game-changer for modifiable risk factors for ulcers, with our findings indicating a feasible and balanced integration into public health systems. Further studies and considerations are vital for informed decisions to stakeholders and the successful implementation of this preventive program on a larger scale.Trial Registration: ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.

Indexed as

Cost-Benefit AnalysisDiabetic FootExercise TherapyAgedAnkleFemaleFootHumansInternetMaleMiddle AgedQuality-Adjusted Life YearsTreatment OutcomeCost-effectivenessDiabetic neuropathiesFoot exercise therapyPreventionRehabilitation technology

Identifiers

PMID38997439
PMCPMC11245594

What OpenQuestion holds

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LicenceCC BY
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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.