Extracorporeal shockwave therapy in the treatment of chronic diabetic foot ulcers: a prospective randomised trial

Objective: To investigate the efficacy of extracorporeal shockwave therapy (ESWT) on healing chronic diabetic foot ulcers (DFU). Method: Patients with chronic DFUs were randomised (1: 1) to receive a series of six ESWT treatments over 3 weeks in combination with standard care or standard care alone. ESWT was performed on DFUs using 250 shocks/cm(2) and 500 shocks on arterial beds supplying the ulcer location. Results: We recruited 23 patients, 11 in the intervention group and 12 in the control. Transcutaneous oxygen tension was significantly increased in patients treated with ESWT compared with those receiving standard care alone at 3 weeks (p=0.044). Ulcer area reduction was 34.5% in the intervention group versus 5.6% in the control group at 7 weeks (p=0.387). Within-group analysis revealed a significant reduction of ulcer area in the intervention group (p<0.01), while healing was not demonstrated in the control group (p>0.05) (data tested for trend). Conclusion: This randomised study indicates a potential beneficial effect of ESWT on ulcer healing as well as tissue oxygenation. Owing to weaknesses of the study and the fact that ulcer healing was not significantly improved in the intervention group compared with the control group, a larger randomised trial with blinded design is suggested.