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

Area of Science:

• Regenerative Medicine
• Wound Healing
• Clinical Trial Methodology

Background:

• Diabetes-related foot ulcers (DFU) represent a significant clinical challenge requiring effective treatment interventions.
• Extracorporeal shockwave therapy (ESWT) is a potential therapeutic modality for promoting DFU healing.
• The feasibility of conducting a large-scale trial for ESWT in DFU patients needs to be established.

Purpose of the Study:

• To assess the deliverability and feasibility of a proposed randomized controlled trial (RCT) investigating ESWT for DFU healing.
• To evaluate secondary outcomes including DFU healing time, quality of life, and healthcare resource utilization.

Main Methods:

• A pilot, double-blinded, randomized controlled trial was conducted.
• Eligible patients with DFU were randomized to receive high-dose ESWT (500 shocks/cm²), low-dose ESWT (100 shocks/cm²), or sham ESWT, in addition to standard care.
• Follow-up extended to 24 weeks, with deliverability assessed by recruitment and retention rates, and secondary outcomes measured.

Main Results:

• A total of 74 patients were recruited, with high follow-up attendance rates (97.3% at 6 weeks, 93.2% at 12 weeks, 87.8% at 24 weeks), demonstrating trial deliverability.
• Median DFU healing times were 54.0 days (high dose), 78.5 days (low dose), and 83.0 days (sham).
• The low-dose ESWT group exhibited the lowest healthcare resource use, and quality of life (EQ-5D-5L utility values) improved across all groups by 24 weeks.

Conclusions:

• The pilot trial successfully demonstrated patient willingness to engage in ESWT research for DFU, confirming the feasibility of the proposed trial design.
• Findings suggest that low-dose ESWT may be a cost-effective option, warranting further investigation in a definitive trial.
• This study provides a strong foundation for conducting a larger definitive RCT to establish the efficacy of ESWT for DFU treatment.