84 Extracorporeal Shockwave Therapy for Diabetes Related Foot Ulcers: A Pilot Three Arm Double Blinded Randomised Controlled Trial

Abstract Background There is an urgent need for effective interventions to aid diabetes related foot ulcer (DFU) healing. This study aimed to test the deliverability of a proposed definitive trial exploring the clinical efficacy of Extracorporeal Shockwave Therapy (ESWT) in DFU healing. Methods A pilot double-blinded three-arm randomised controlled trial. Patients with a DFU present for ≥4 weeks were randomised to high dose (500shocks/cm2), low dose (100shocks/cm2) or sham (0shocks/cm2) ESWT, in addition to standard care. Follow-up was at 6-, 12- and 24-weeks post randomisation. The primary outcome was deliverability of the proposed trial. The secondary outcomes were ulcer healing, quality-of-life and healthcare resource use. Results 904 patients were screened between 26/05/2022 - 31/10/2023, 141 (15.6%) patients were eligible, and 74 (52.5%) patients were recruited. Adherence to treatment was 94.6%(70/74). Follow-up attendance was 97.3% (72/74), 93.2% (69/74) and 87.8% (65/74) at 6, 12 and 24 weeks. The median DFU healing time in high dose, low dose and sham ESWT arms was 54.0 (IQR 119.0), 78.5 (IQR 61.0) and 83.0 (IQR 85.0) days. The mean EQ-5D-5L utility value in the high dose, low dose and sham ESWT arms at 24 weeks was 0.621 (95% CI 0.438-0.804), 0.779 (95% CI 0.683- 0.876 and 0.806 (95% CI 0.717- 0.895). Participants in the high dose and sham ESWT arms used more healthcare resources. Conclusion The pilot trial has demonstrated that patients with a DFU are willing to engage in the proposed trial and suggests the optimal way to deliver the definitive trial.