O17: ‘I had to do something’: A qualitative study of patients and healthcare professionals engagement in an interventional diabetic foot ulcer trial

Abstract Background Development of interventions to improve diabetic foot ulcer(DFU) healing is vital, however trials typically under-recruit and translation of effective interventions is limited. This study explores patient and clinician perceptions of Extracorporeal Shockwave Therapy(ESWT) and the SOLEFUL Trial(randomised control trial of ESWT for DFU). Methods Maximum variable sampling technique was used to recruit participants from one tertiary centre and clinicians nationally. Semi-structured interviews were conducted, audio-recorded and transcribed verbatim in four participant groups (participants, dropouts, decliners, and clinicians). Data were analysed with an inductive exploratory approach using reflexive thematic analysis. Results 18 participants, 1 dropout, 3 decliners and 10 clinicians took part. Drivers for participation included desperation for healing and curiosity in a new intervention. Participants perceived the trial offered holistic healthcare, referencing quality-of-life questionnaires and telephone follow-ups. ESWT was viewed as hassle-free and painless, compared to alternatives. Barriers to participation included impact of competing comorbidities and belief care cannot be improved. In contrast, clinicians discussed mechanisms of action, effectiveness, and implementation of new technologies. Conclusion This study highlighted key drivers for trial engagement/disengagement in patients with DFUs and their clinicians. These factors must be respected in trial design and delivery to aid successful development of new DFU interventions.