Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04042285
• Other study ID #: R2158
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: May 20, 2022

Study information

• Verified date: October 2021
• Source: Hull University Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: May 20, 2022
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of diabetes mellitus
• Open surgical wound of the foot
• ABPI >0.8
• Age greater than 18 years old
• Able and willing to give written informed consent
• Be able to adhere to protocol and attend all follow up appointments

Exclusion Criteria:

• Pregnancy or breast-feeding
• Current malignancy
• Allergy to materials used in the treatment
• Palliative
• Unable or unwilling to give consent
• Anticoagulation

Related Conditions & MeSH terms

• Diabetic Foot
• Wound
• Wounds and Injuries

Intervention

Device:
• Extracorporeal shockwave therapy
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.

Other:
• Standard Wound Care
dressing changes, negative pressure wound therapy, offloading footwear, debridement, glycaemic control and antibiotics as necessary

Locations

Country	Name	City	State
United Kingdom	Hull and East Yorkshire Hospitals NHS Trust	Hull

Sponsors (2)

Lead Sponsor	Collaborator
Hull University Teaching Hospitals NHS Trust	University of Hull

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound volume	Change in wound volume between study visits	Baseline, up to 7 days, 4 weeks, 8 weeks, 12 weeks
Secondary	Pain Score Questionnaire	Brief Pain Inventory and Visual Analogue Scale	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	Quality of Life Questionnaire	SF-12 and EQ-5Q-3L	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	Infection rate	The number of wounds which develop an infection in the study period	Recorded at evey study contact
Secondary	Amputation rate	The number of amputations of treated sites in the study period	Recorded at every study contact
Secondary	Local perfusion rate	blood flow perfusion rate of superficial tissues using Doppler flowmetry	Baseline, up to 7 days
Secondary	Tissue integrity	Tissue hydration determined by a vapometer	Baseline, up to 7 days