Background: Diabetes mellitus (DM) is a chronic and complex disease, which is a major
cause of morbidity and mortality and affects all age groups. It commonly produces secondary
effects on the foot, often making daily activities impossible. Patient-reported outcome measures
(PROMs) provide a standardised method of obtaining patients’ outlooks on their functional status
and wellbeing. Although many instruments have been proposed for obtaining data on persons
with DM whose feet are affected by the disease, in many cases the psychometric properties of
the instrument have yet to be established. The principal objective of our review was to identify
PROMs specific for patients with DM affecting the foot and ankle and to evaluate the psychometric
properties and methodological quality of these instruments. Methods: In this systematic review, we
investigate studies (published in English or Spanish) based on the use of one or more PROMs specific
to foot and ankle pathologies for patients with DM (type I or II). To do so, the databases PubMed,
Scopus, CINAHL, PEDro and Google Scholar were searched for studies that analysed psychometric
or clinimetric properties in this respect. These were assessed according to Terwee or COSMIN criteria.
Results: Of the 1016 studies identified in the initial search, only 11 were finally included in the
qualitative review. Analysis according to Terwee and COSMIN criteria showed that the Foot Health
Status Questionnaire (FHSQ) presented the greatest number of positive values. Conclusions: The
FHSQ is the highest-quality PROM currently available for the foot and ankle, for patients with DM.
