ArticleBMJ open2025
Diabetic foot ulcer photography study: a study within a trial to assess the reliability of two-dimensional (2D) photography for the assessment of ulcer healing in patients with diabetes-related foot ulcers-protocol paper.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Swabs versus tissue samples for infected diabetic foot ulcers: the CODIFI2 RCT.Health technology assessment (Winchester, England) · 2025Trial
- Clinical applications of machine learning for infection assessment in diabetic foot ulcers.Frontiers in physiology · 2026Review
- Management of severe diabetic foot using modified transverse bone transport: A retrospective study of Wagner grade 3 to 4 cases.Medicine · 2025Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe primary endpoint in diabetes-related foot ulcer (DFU) trials is often time to healing, defined as complete re-epithelialisation with absence of drainage, requiring clinical expert assessment as the gold standard. Central blinded photograph review for confirmation of healing is increasingly being undertaken for internal validity. The Diabetic Foot Ulcer Photography study aims to determine the agreement between blinded independent review panel members for assessing ulcer healing status in patients with DFUs. METHODS AND ANALYSIS: Photographs of ulcers clinically assessed as healed or not healed across 300 participants recruited to one of two randomised controlled trials (MIDFUT and CODIFI2), will be independently reviewed by a central blinded panel consisting of four clinicians with expertise in ulcer healing assessment. Staff at recruiting sites will take photographs using a standardised camera and protocol. Photographs will be reviewed at three levels of magnification: raw image, image standardised to a measurement scale included in the photograph and standardised image with magnification permitted. Reviewers will assess the healing status and their confidence level in making a healing judgement, with reasons reported for a low confidence rating. Analysis at each level of magnification will estimate inter- and intra-rater reliability on the assessments of healing of photographs with the clinical assessment (primary) and confidence rating using multivariable logistic mixed models. Analysis of the learning curve for the assessment of healing and confidence rating will use exponential and two-phase models. ETHICS AND DISSEMINATION: Ethics approval has been granted by the National Research Ethics Service Committees (MIDFUT 17/YH/0055; CODIFI2 18-WS-0235). All participants will provide a written informed consent for photography before recruited onto the respective study. Photographs will be transferred to the trials' coordinating centre via a secure file transfer service and saved in a restricted access folder on a secure server. Results will be disseminated via publications in scientific journals and conference presentations. TRIAL REGISTRATION NUMBER: MIDFUT (ISRCTN64926597) and CODIFI2 (ISRCTN74929588).
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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.