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Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality
Open accessAbstract
The evidence base for many aspects of the management of foot ulcers in people with diabetes is weak, and good-quality research, especially relating to studies of direct relevance to routine clinical care, is needed. In this paper, we summarise the core details required in the planning and reporting of intervention studies in the prevention and management of diabetic foot ulcers, including studies that focus on off-loading, stimulation of wound healing, peripheral artery disease, and infection. We highlight aspects of trial design, conduct, and reporting that should be taken into account to minimise bias and improve quality. We also provide a 21-point checklist for researchers and for readers who assess the quality of published work.
Overview
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TL;DR
This Personal View from the International Working Group on the Diabetic Foot and the European Wound Management Association proposes reporting standards and a 21-point quality checklist for intervention studies on prevention and management of diabetic foot ulcers. It argues that poor reporting and heterogeneous study details have undermined the evidence base in this field.
Key findings
- The paper defines core population, intervention, and outcome details that should be reported in studies of diabetic foot ulcer prevention and management, with separate tables for prevention versus management and for off-loading, peripheral artery disease, and infection.
- It provides a 21-point scoring system for reports of clinical studies, with each item scored 1 point if the desired answer is “yes”; the maximum score is 21.
- It reports that ulcer recurrence is roughly 30–40% in the first 12 months after healing, and that in an unselected low-risk UK diabetes population new ulceration is roughly 2% per year; approximately 10,000 individuals would be needed to show a reduction in ulcer incidence to 1.5%, depending on study duration, withdrawals, and power.
- For ulcer management studies with an intervention phase of 20 weeks or more, the authors state that attrition should be no greater than 25%.
Methods
- Design: Personal View/expert-opinion guidance developed on behalf of the International Working Group on the Diabetic Foot and the European Wound Management Association.
- Data/sample: No original patient sample or systematic data collection is reported; the paper synthesises prior systematic reviews, existing reporting guidelines such as CONSORT, STROBE, PRISMA, and GRADE, and EWMA chronic-wound guidance.
- Main analysis: Narrative synthesis and expert consensus, producing tables of core reporting details and a 21-item checklist for study design, conduct, outcomes, and reporting.
Limitations
- The paper states it is based on expert opinion, that production of lists of required data is “fraught with difficulty,” and that it is not possible to be more dogmatic because required details differ by study type.
- The paper states that criteria have yet to be established to determine how the 21-point checklist scores can be stratified into appropriate levels of quality.
- The paper states its scope excludes non-interventional observational research, animal models, work on specific underlying biological mechanisms, and health-economic aspects; it also notes no consensus exists on acceptable retention/attrition, with the 25% threshold given as the authors’ opinion.
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Claims the paper makes
0 Valid · 2 Not valid · 10 Not checked · 24 Own results and interpretations
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“through doing repeated systematic reviews, we found that existing tools for assessing the literature do not fully meet the needs of research in this complex clinical area”
§ Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality > Introduction
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A further problem inherent in the use of either the number (or percentage) of ulcers healed by a fi xed time or the time to healing is that these metrics are directly related to baseline ulcer area, because larger ulcers take longer to heal.”
§ Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality > Outcomes
plainstates a cause- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: unclear — It is unclear why the paper says it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The lower the rate of retention (ie, the higher the rate of attrition or loss to follow-up), the greater the likelihood of bias in any observations made.”
§ Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality > Study conduct: retention and attrition (item 13)
hedgedstates an association- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: unclear — It is unclear why the paper says it holds.
None of the sources cited for this claim could be matched to a paper in Crossref, so there is nothing to check it against.
In the paper
“the number of reports of high-quality research into interventions for diabetic foot ulcers has remained low.[2][3][4][5][6]”
§ Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality > Introduction
What the sources say
- Not matchedcites [2]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Not matchedcites [3]
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plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Not matched
None of the sources cited for this claim could be matched to a paper in Crossref, so there is nothing to check it against.
In the paper
“their prevention and management are undermined by the scarcity of evidence on which to base treatment choices.”
§ Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality > Introduction
What the sources say
- Not matchedcites [2]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Not matchedcites [3]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Not matchedcites [4]
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plainstates a cause- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Not matched
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Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“Despite these differences, six of the outcomes in the COS, including wound healing, time to healing, minor amputation, major amputation, health-related quality of life, and mortality, were already recommended as the key quality measures for studies on interventions for diabetes-related foot ulceration by IWGDF and European Wound Management Association.”
From Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration (2024) · cites this paper as [7]
In the citing paper
“IWGDF and the European Wound Management Association have previously jointly published guidance on the core planning and reporting details for studies on prevention and management of diabetic foot ulceration (7).”
From Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration (2024) · cites this paper as [7]
In the citing paper
“Nonetheless, this statement was a product of expert panel discussion rather than a formal methodological approach with active patient and public involvement.”
From Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration (2024) · cites this paper as [7]
Citations
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Metadata
- Authors
- Jeffcoate, W. J., Bus, S. A., Game, F. L., Hinchliffe, R. J., Price, P. E., & Schaper, N. C.
- Affiliations
- Nottingham University Hospitals NHS Trust (GB)
- Amsterdam UMC Location University of Amsterdam (NL)
- National Health Service (GB)
- St George's Hospital (GB)
- Cardiff University (GB)
- Maastricht University Medical Centre (NL)
- Corresponding author
- Jeffcoate, William J
- ORCID
- Venue
- The Lancet Diabetes & Endocrinology
- Publisher
- Elsevier BV
- Published
- 2016-09
- Volume
- 4
- Issue
- 9
- Pages
- 781-788
- ISSN
- 2213-8587 (ISSN-L)
- OpenAlex
- W2385395211
- Semantic Scholar
- 5537c4b45290bb52e121b9172e5465666c6091cc
- Cited by
- 234
- References
- 25
- Citations by year
- 2026: 21 · 2025: 12 · 2024: 23 · 2023: 32 · 2022: 29 · 2021: 18 · 2020: 39 · 2019: 18 · 2018: 23 · 2017: 13 · 2016: 5
- FWCI
- 13.59
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- www.elsevier.com/legal/tdmrep-license (tdm)
- Locations
- The Lancet Diabetes & Endocrinology (publishedVersion)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, other-oa)
- Explore Bristol Research (publishedVersion, cc-by-nc-nd)
- Bristol Research (University of Bristol) (acceptedVersion, cc-by-nc-nd)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Cronfa (Swansea University) (submittedVersion)
- ORCA Online Research @Cardiff (Cardiff University) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- diabetic foot ulcer, foot ulcer prevention, foot ulcer management, reporting quality, bias in clinical trials, offloading, wound healing stimulation, peripheral arterial disease, infection, trial design
- MeSH terms
- Clinical Trials as Topic, Humans, Diabetic Foot
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-11-13, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-11-13 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
