Trial reportPloS one2019
Clinical efficacy of therapeutic footwear with a rigid rocker sole in the prevention of recurrence in patients with diabetes mellitus and diabetic polineuropathy: A randomized clinical trial.
Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02995863 (Clinical Efficacy of Therapeutic Footwear With a Rigid Rocker Sole in the Prevention of Reulceration in Patients With Diabetes Mellitus and Diabetic Polineuropathy), which is not on this map. Cited by 26 papers, 4 of them syntheses that pooled 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.
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.
Clinical Efficacy of Therapeutic Footwear With a Rigid Rocker Sole in the Prevention of Reulceration in Patients With Diabetes Mellitus and Diabetic Polineuropathy: a Prospective and Randomized Clinical Trial.
Who cites it
26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- Prevention of foot ulcers recurrence in patients with diabetes: a systematic review and meta-analysis of randomized controlled trials for the development of the italian guidelines for the treatment of diabetic foot syndrome.Acta diabetologica · 2024Pooled it
- Effects of Special Therapeutic Footwear on the Prevention of Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Journal of diabetes research · 2022Pooled it
- Footwear and insole design features for offloading the diabetic at risk foot-A systematic review and meta-analyses.Endocrinology, diabetes & metabolism · 2021Pooled it
- Footwear and insole design features that reduce neuropathic plantar forefoot ulcer risk in people with diabetes: a systematic literature review.Journal of foot and ankle research · 2020Pooled it
- Tandem mass tag-based serum proteomic profiling revealed diabetic foot ulcer pathogenesis and potential therapeutic targets.Bioengineered · 2022Trial
- Therapeutic footwear in patients with diabetes: a position statement from the Italian diabetic foot study group.Acta diabetologica · 2026Review
- Current strategies and priorities for diabetic footwear design and production: a cross-European exploratory survey of clinicians and shoemakers.Acta diabetologica · 2026Article
- What Footwear Do People with Diabetes Mellitus Use? A Narrative Review.Journal of clinical medicine · 2025Review
- Short-Term Efficacy of a Multi-Modal Intervention Program to Improve Custom-Made Footwear Use in People at High Risk of Diabetes-Related Foot Ulceration.Journal of clinical medicine · 2025Article
- Finite-element analysis-based design and efficacy assessment of a three-dimensional anisotropic heel cushioning pad for diabetic foot management.Frontiers in bioengineering and biotechnology · 2025Article
- Recurrence rates after healing in patients with neuroischemic diabetic foot ulcers healed with and without sucrose octasulfate-impregnated dressings: A 1-year comparative prospective study.International wound journal · 2024Article
- The efficacy of custom-made offloading devices for diabetic foot ulcer prevention: a systematic review.Diabetology & metabolic syndrome · 2024Review
- The Appropriateness of Footwear in Diabetic Patients Observed during a Podiatric Examination: A Prospective Observational Study.Journal of clinical medicine · 2024Article
- In-Shoe Pressure Measurements in Diabetic Footwear Practice: Success Rate and Facilitators of and Barriers to Implementation.Sensors (Basel, Switzerland) · 2024Article
- Offloading and adherence through technological advancements: Modern approaches for better foot care in diabetes.Diabetes/metabolism research and reviews · 2024Review
- Patients' Buying Behavior for Non-Reimbursed Off-Loading Devices Used in Diabetic Foot Ulcer Treatment-An Observational Study during COVID-19 Pandemic from a Romanian Physical Therapy Unit.Journal of clinical medicine · 2023Article
- Article
- Orthotic approach to prevention and management of diabetic foot: A narrative review.World journal of diabetes · 2022Review
- Safety and Efficacy of Several Versus Isolated Prophylactic Flexor Tenotomies in Diabetes Patients: A 1-Year Prospective Study.Journal of clinical medicine · 2022Article
- Prevention of Peripheral Distal Polyneuropathy in Patients with Diabetes: A Systematic Review.Journal of clinical medicine · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTherapeutic footwear becomes the first treatment line in the prevention of diabetic foot ulcer and future complications of diabetes. Previous studies and the International Working Group on the Diabetic Foot have described therapeutic footwear as a protective factor to reduce the risk of re-ulceration. In this study, we aimed to analyze the efficacy of a rigid rocker sole to reduce the recurrence rate of plantar ulcers in patients with diabetic foot.
methodsBetween June 2016 and December 2017, we conducted a randomized controlled trial in a specialized diabetic foot unit. PARTICIPANTS AND
interventionFifty-one patients with diabetic neuropathy who had a recently healed plantar ulcer were randomized consecutively into the following two groups: therapeutic footwear with semi-rigid sole (control) or therapeutic footwear with a rigid rocker sole (experimental). All patients included in the study were followed up for 6 months (one visit each 30 ± 2 days) or until the development of a recurrence event. MAIN OUTCOME AND MEASURE: Primary outcome measure was recurrence of ulcers in the plantar aspect of the foot.
findingsA total of 51 patients were randomized to the control and experimental groups. The median follow-up time was 26 [IQR-4.4-26.1] weeks for both groups. On an intention-to-treat basis, 16 (64%) and 6 (23%) patients in the control and experimental groups had ulcer recurrence, respectively. Among the group with >60% adherence to therapeutic footwear, multivariate analysis showed that the rigid rocker sole improved ulcer recurrence-free survival time in diabetes patients with polyneuropathy and DFU history (P = 0.019; 95% confidence interval, 0.086-0.807; hazard ratio, 0.263).
conclusionsWe recommend the use of therapeutic footwear with a rigid rocker sole in patients with diabetes with polyneuropathy and history of diabetic foot ulcer to reduce the risk of plantar ulcer recurrence.
trial registrationClinicalTrials.gov NCT02995863.
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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.