Development of a core descriptor set for studies assessing interventions for diabetes-related foot ulceration
AIMS/HYPOTHESIS: Foot ulceration is a common complication of diabetes and is associated with high mortality and costs. The quality of evidence to inform clinical practice is limited, partly because clinical studies do not consistently report baseline participant characteristics. This study aimed to develop a core descriptor set (CDS), a minimum set of descriptors to be measured in all studies evaluating interventions for people with diabetes-related foot ulceration. METHODS: A longlist of descriptors was generated through a systematic review of studies assessing interventions for diabetes-related foot ulcers, pre-registered with PROSPERO (CRD42019128250). The identified descriptors were then ranked based on perceived importance by healthcare professionals from different fields and geographical locations using a nine-point Likert scale in the first round of a Delphi survey. Using standardised criteria, descriptors without consensus were re-ranked in round two. Critical descriptors and those without consensus after the Delphi process were discussed in the consensus meeting to finalise the CDS. RESULTS: The systematic review yielded 95 candidate descriptors. The two Delphi rounds were completed by 102 and 69 healthcare professionals, respectively. The Delphi process identified 34 critically important descriptors and 13 descriptors without consensus, which were discussed in the consensus meeting. The ratified CDS included 28 descriptors across nine domains: demographic variables; individual factors; ulcer characteristics; limb characteristics; ongoing medical interventions; previous surgical interventions; medication history; biochemical measurements; and quality of life/function/symptoms. CONCLUSIONS/INTERPRETATION: This CDS reflects characteristics important to health professionals and researchers when reporting clinical studies on diabetes-related foot ulceration. Its use will aid the reporting of future studies.
Authors
- Dane K. Wukich (ORCID: https://orcid.org/0000-0002-3637-6208)
- Aleksandra Staniszewska (ORCID: https://orcid.org/0000-0002-8917-1281)
- Venu Kavarthapu (ORCID: https://orcid.org/0000-0002-7184-4433)
- David Russell (ORCID: https://orcid.org/0000-0002-1293-5618)
- Vivienne Chuter (ORCID: https://orcid.org/0000-0003-4793-5340)
- Sicco A. Bus (ORCID: https://orcid.org/0000-0002-8357-9163)
- Emma Hamilton (ORCID: https://orcid.org/0000-0003-1617-6353)
- Robert J. Hinchliffe (ORCID: https://orcid.org/0000-0002-6370-0800)
- Michael Edmonds (ORCID: https://orcid.org/0000-0002-8931-0069)
- Jane Nixon (ORCID: https://orcid.org/0000-0003-1705-7698)
- Matilde Monteiro‐Soares (ORCID: https://orcid.org/0000-0002-4586-2910)
- Jaap J. van Netten (ORCID: https://orcid.org/0000-0002-6420-6046)
- Frances L. Game (ORCID: https://orcid.org/0000-0002-5294-4789)
- Edgar J.G. Peters (ORCID: https://orcid.org/0000-0002-3410-1227)
- Jayer Chung (ORCID: https://orcid.org/0000-0001-6404-4414)
- Robert Fitridge (ORCID: https://orcid.org/0000-0001-6258-5997)
- Ketan Dhatariya (ORCID: https://orcid.org/0000-0003-3619-9579)
- Catherine Gooday (ORCID: https://orcid.org/0000-0001-5026-6788)
- Joseph Shalhoub (ORCID: https://orcid.org/0000-0003-1011-7440)
- Joseph L. Mills (ORCID: https://orcid.org/0000-0002-4955-4384)
- Amy Jones (ORCID: https://orcid.org/0009-0002-3969-3345)
- Luke Davies (ORCID: https://orcid.org/0009-0005-4574-5529)
Institutions
- University of East Anglia (GB)
- Camden and Campbelltown Hospitals (AU)
- North Bristol NHS Trust (GB)
- University of Leeds (GB)
- Royal Adelaide Hospital (AU)
- Imperial College Healthcare NHS Trust (GB)
- Baylor College of Medicine (US)
- Norfolk and Norwich University Hospitals NHS Foundation Trust (GB)
- Fiona Stanley Hospital (AU)
- At Bristol (GB)
- Portuguese Army (PT)
- University of Bristol (GB)
- Netherlands Center for Occupational Diseases (NL)
- King's College Hospital NHS Foundation Trust (GB)
- Centre for Health Technology and Services Research (PT)
- University Hospitals of Derby and Burton NHS Foundation Trust (GB)
- Amsterdam University Medical Centers (NL)
- King's College Hospital (GB)
- Western Sydney University (AU)
- Green Cross International (US)
- Vrije Universiteit Amsterdam (NL)
- The University of Texas Southwestern Medical Center (US)
- University of Amsterdam (NL)
Publication Details
- Journal
- Diabetologia
- Published
- 2026-07-25
- DOI
- https://doi.org/10.1007/s00125-026-06815-1
- Primary Topic
- Diabetic Foot Ulcer Assessment and Management
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Institute for Health and Care Research
- Department of Health and Social Care
- Leeds Biomedical Research Centre