NCT04042285

Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

Extracorporeal Shockwave Therapy for Diabetic Foot Wounds: A Cohort Study Comparing Extracorporeal Shockwave Therapy to Standard Treatment for Diabetic Foot Wounds

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Hull University Teaching Hospitals NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Diabetic wounds post digital amputation have poor healing in 30-45% of cases, resulting in 75% of patients undergoing a further amputation within the year, despite best wound management. Extracorporeal shockwave therapy is a promising safe and non invasive treatment that has been shown to improve healing in chronic ulcers and burns by promoting healing and decreasing risk of infection. The study will recruit patients on a hospital ward and outpatient departments who have a diabetic foot wound. Participants will be informed about the study, given an patient information sheet and invited to give informed consent. Consenting participants will undergo shockwave therapy three times in the seven days after their operation, in addition to standard wound care. Wound measurements, blood perfusion, tissue integrity, quality of life and pain scores will be recorded at baseline, after the third treatment, 4 weeks, 8 weeks and 12 weeks after recruitment to the study. The study aims to recruit 25 patients.

Conditions

• Diabetic Foot
• Wound

Interventions

Type	Name	Description
DEVICE	Extracorporeal shockwave therapy in addition to standard care	Extracorporeal shockwave therapy will be given at 120 pulses/cm2, penetration 5mm at a dose of 0.1mJ/mm2 at 5 pulses/second. Participants will receive 3 sessions of shockwave therapy in a 7-day period. Standard care as per the NICE and IWGDF guidelines.

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-02-02
• Completion: 2022-05-13
• First posted: 2019-08-01
• Last updated: 2025-03-28
• Results posted: 2025-03-28

Locations

1 site across 1 country: United Kingdom