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Clinical Trial 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 who have undergone a toe amputation for a infected non healing diabetic foot ulcer. 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. The results will be compared to a matched retrospective cohort group who received standard wound care.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04042285
Study type Interventional
Source Hull University Teaching Hospitals NHS Trust
Contact
Status Active, not recruiting
Phase N/A
Start date February 1, 2019
Completion date May 20, 2022

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