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).


METHODS
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/cm2and 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).


CONCLUSIONS
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.
PhD student, Professor, Consultant Urology, Department of Urology, Odense University Hospital, Odense, Denmark.|PhD student, OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
S M
SM
Jeppesen
Associate Professor, Consultant Medical Endocrinology and Internal Medicine, Department of Endocrinology, Odense University Hospital, Odense, Denmark.
K B
KB
Yderstraede
Resident, Department of Radiology, Odense University Hospital, Denmark.
B S B
BS
Rasmussen
Consultant Urology, Department of Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.
M
M
Hanna
PhD student, Professor, Consultant Urology, Department of Urology, Odense University Hospital, Odense, Denmark.|Professor, Consultant Urology, Clinical Institute, University of Southern Denmark, Odense, Denmark.
L
L
Lund
D000368:Aged; D002908:Chronic Disease / Q000628:therapy*; D017719:Diabetic Foot / Q000628:therapy*; D005260:Female; D019220:High-Energy Shock Waves / Q000627:therapeutic use*; D006801:Humans; D006931:Hyperbaric Oxygenation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology*
ESWT; diabetes mellitus; diabetic foot ulcer; extracorporeal shockwave therapy; tissue oxygenation; transcutaneous oxygen tension; wound healing