PONE-D-24-01745In- Shoe Plantar Shear Stress Sensor Design, Calibration and Evaluation for the Diabetic Foot.PLOS ONE

Dear Dr. Weightman,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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ACADEMIC EDITOR: The authors provided a study presenting the design of a shear stress sensor for diabetic foot monitoring. This study was evaluated by two experts in the field who acknowledged the significance of the research. However, they also highlighted several major and minor issues that need addressing before the manuscript can be accepted. Additionally, based on my expertise in the field, I observed a deficiency in the potential application of such a sensor concerning the data it provides. For this reason, I suggest that the authors also review recent literature that could bolster the sensor's applicability in diagnostic schemes. The pressure information related to diabetic feet can be particularly valuable in posturography, as suggested by Mengarelli, Alessandro, et al. in "Multiscale Fuzzy Entropy Analysis of Balance: Evidences of Scale-Dependent Dynamics on Diabetic Patients with and without Neuropathy," published in IEEE Transactions on Neural Systems and Rehabilitation Engineering 31 (2023): 1462-1471.

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We look forward to receiving your revised manuscript.

Kind regards,

Andrea Tigrini, Ph.D.

Academic Editor

PLOS ONE

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Additional Editor Comments:

The authors provided a study presenting the design of a shear stress sensor for diabetic foot monitoring. This study was evaluated by two experts in the field who acknowledged the significance of the research. However, they also highlighted several major and minor issues that need addressing before the manuscript can be accepted. Additionally, based on my expertise in the field, I observed a deficiency in the potential application of such a sensor concerning the data it provides. For this reason, I suggest that the authors also review recent literature that could bolster the sensor's applicability in diagnostic schemes. The pressure information related to diabetic feet can be particularly valuable in posturography, as suggested by Mengarelli, Alessandro, et al. in "Multiscale Fuzzy Entropy Analysis of Balance: Evidences of Scale-Dependent Dynamics on Diabetic Patients with and without Neuropathy," published in IEEE Transactions on Neural Systems and Rehabilitation Engineering 31 (2023): 1462-1471.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The Authors presented a work aimed at proposing the design and calibration of an in-shoe plantar shear stress sensor for applications in the assessment of diabetic foot ulceration. Specifically, focus is made on the evaluation in terms of sensor loading area and location. The manuscript is generally well written, but needs improvement. My major concern is about the description of the performed experiments in the methodology section. Indeed, the subdivision followed to describe calibration procedure and validation procedure is confusing thus not allowing the optimal fruition on what steps have been followed (e.g., the gait laboratory treadmill walking test is introduced at line 236 but participants are mentioned also in previous sections in the text). Providing an outline of the methodology content and/or improving subsections’ subtitles may be of help. Further minor comments are provided in the following.

- How were the compressive strains values for ε1 and ε2 determined? Please provide a brief sentence.

- In Fig. 2 label, “SSS” acronym is not defined. Same for “DAQ” in Fig. 3. Figures' labels should be self explaining.

- Line 185: call to the figure is not clear.

- Line 205-207: the sentence is not clear, please rephrase. Some interrupted sentences are present in the text.

- The reported state of art literature regarding the context in which the presented study may find application is very specific. I suggest the Authors to broaden the research context description by mentioning more in general where is the state of art for DFU risk prediction, in order to help the more general part of the Journal’s readership to become aware on the strength of the proposed work. Regarding to this, a recent review on “artificial intelligence methodologies applied to technologies for screening, diagnosis and care of the diabetic foot” may provide insightful information on which quantitative measures are suggested for an early identification of DFU risk, including plantar-based measurements. Indeed, in my opinion the quantitative information provided by shear stress measurement may also be used in artificial intelligence based approaches for the prediction of diabetic foot ulceration.

Reviewer #2: Manuscript title: In- Shoe Plantar Shear Stress Sensor Design, Calibration and Evaluation for the Diabetic Foot.

This work investigated the pressing issue of Diabetic Foot Ulceration (DFU), a significant global healthcare challenge. It highlights the crucial need for technology to identify the onset of DFU, enabling timely intervention, improving healthcare delivery, and reducing economic costs associated with its management. Specifically, the study focuses on the role of high-foot plantar stresses, including shear stress, in the formation of DFUs. It acknowledges the challenges in accurately measuring shear stress and the limited research in this area. It's commendable that the paper is well-written.

comments

• The abstract should emphasize the novelty of the research findings.

• The introduction section is crucial, but the author hasn't given it sufficient attention. It should include a discussion of currently available research.

• Abbreviations should be explained at the beginning. In the Methods section, there is confusion regarding the symbols used.

• The author should explain the effect of silicone stiffness on the strain gauge rosette.

• More detailed explanations of the experimental setup and testing methods are needed, including the number of subjects and their body parameters.

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Reviewer #1: No

Reviewer #2: Yes: Akhil V M

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Attachments

Attachment

Submitted filename: Comments New.pdf

PONE-D-24-01745R1In- Shoe Plantar Shear Stress Sensor Design, Calibration and Evaluation for the Diabetic Foot.PLOS ONE

Dear Dr. Weightman,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

==============================

ACADEMIC EDITOR: Authros addressed the majority of the points.  However, some minor concerns still need revision.

==============================

Please submit your revised manuscript by Aug 30 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Andrea Tigrini, Ph.D.

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments:

Authros addressed the majority of the points. However, some minor concerns still need revision.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: (No Response)

Reviewer #2: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: N/A

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4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The Authors responded to almost all Reviewers' comments, but information on anthropometric characteristics and body parameters is not yet reported, thus compromising reproducibility. Furthermore, the authors should prefer to use “people with diabetes” or similar, instead of “diabetics”. Even if the effort made to improve the explanation of the methodology is recognisable, Figure 1 should still be referred to in the text wherever necessary (perhaps adding letters to the panels could help this purpose). The resolution of Figure 1 should also be improved.

Reviewer #2: The authors have thoroughly addressed all the comments, demonstrating a positive and constructive approach. They have provided detailed responses and made the necessary revisions to improve the manuscript, ensuring that all concerns and suggestions from the reviewers have been adequately considered and integrated.

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: Yes: AKHIL V M

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[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

In- Shoe Plantar Shear Stress Sensor Design, Calibration and Evaluation for the Diabetic Foot.

PONE-D-24-01745R2

Dear Dr. Weightman,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Andrea Tigrini, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The authors have addressed all comments, and the manuscript is now ready for publication.

Reviewers' comments: