Extracorporeal Shockwave Therapy for Diabetes Related Foot Ulcers: A Pilot Three-Arm Double-Blinded Randomised Controlled Trial.
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All Authors
Hitchman, L.
Lathan, R.
Ravindhran, B.
Sidapra, M.
Long, J.
Cowling, A.
Keding, A.
Watson, J.
Iglesias, C.
Smith, G.
LTHT Author
Russell, David
LTHT Department
Trauma & Related Services
Leeds Vascular Institute
Vascular Surgery
Leeds Vascular Institute
Vascular Surgery
Non Medic
Publication Date
2025
Item Type
Journal Article
Randomised Controlled Trial
Randomised Controlled Trial
Language
Subject
Subject Headings
Abstract
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.
Journal
International Wound Journal