A systematic review of outcome reporting for interventions to treat people with diabetic foot ulceration

George Dovell*, Aleksandra Staniszewska, Jozel Ramirez, Ines Murray, Graeme K Ambler, Christopher P Twine, Robert J Hinchliffe

*Corresponding author for this work

Research output: Contribution to journalReview article (Academic Journal)peer-review

7 Citations (Scopus)
17 Downloads (Pure)


BACKGROUND: Diabetic foot ulceration (DFU) is a challenging clinical problem that affects up to a quarter of patients with diabetes in their lifetime. An agreed set of outcomes for assessing treatments or interventions for DFU has not previously been considered. The aim of this study was to identify outcomes that are reported in clinical studies assessing a treatment or intervention for DFU, to inform the development of a core outcome set (COS).

METHODS: Systematic literature searches were performed between January 2016 and March 2019. The search strategy was pre-registered with PROSPERO (CRD42019128250). Two authors independently screened abstracts for full text review. Outcomes were extracted from selected papers verbatim and categorized into domains according to established taxonomy. Consistency of outcome reporting was assessed. Overlapping outcomes were merged independently to condense the extracted list of outcomes for use in forthcoming consensus processes.

RESULTS: Of 4645 abstracts identified, 114 studies met the inclusion criteria. There were 69 randomized studies, 40 prospective studies and 5 protocols. Some 948 outcomes were extracted verbatim. Outcome reporting was consistent for 474 (53%) outcomes. De-duplication left 714 unique verbatim outcomes across 33 domains. Merging of overlapping unique verbatim outcomes established 95 merged outcomes.

CONCLUSION: This study describes contemporary outcomes reported in studies assessing interventions for DFU. Outcome reporting is considered to be poor as it was consistent in just over half of outcomes extracted. Merging of outcomes has identified 95 outcomes that can be taken forward in the development of a COS.

Original languageEnglish
Article numbere14664
Number of pages9
JournalDiabetic Medicine
Issue number10
Early online date29 Jul 2021
Publication statusPublished - 1 Oct 2021

Bibliographical note

Funding Information:
RJH is supported by the Enid Linder Foundation/Royal College of Surgeons Chair in Clinical Trials in Surgery.

Publisher Copyright:
© 2021 Diabetes UK.


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