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

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 trial of extracorporeal shockwave therapy (ESWT) for DFU healing. A pilot double-blinded randomised controlled trial. Patients with a DFU present for ≥ 4 weeks were randomised to high dose (500 shocks/cm2), low dose (100 shocks/cm2) or sham (0 shocks/cm2) ESWT, plus standard care. Follow-up was for 24 weeks. Primary outcome was deliverability of the trial. Secondary outcomes were healing, quality of life and healthcare resource use. One-hundred and forty-one (15.6%) screened patients were eligible and 74 (52.5%) patients were recruited. 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 was high dose: 54.0 (IQR 119.0), low dose: 78.5 (IQR 61.0) and sham: 83.0 (IQR 85.0) days. The mean EQ-5D-5L utility value at 24 weeks was high dose: 0.621 (95% CI 0.438–0.804), low dose: 0.779 (95% CI 0.683–0.876) and sham: 0.806 (95% CI 0.717–0.895). Healthcare resource use was lowest in the low-dose ESWT arm. The pilot trial has demonstrated that patients with a DFU are willing to engage in the proposed trial and suggest the optimal way to deliver the definitive trial.