Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

NCT ID: NCT04042285

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-05-13

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Extracorporeal shockwave therapy

The shockwave therapy will be given at 120 pulses/cm2, penetration 5mm at a dose of 0.1mJ/mm2 at 5 pulses/second (17). Participants will receive 3 sessions of shockwave therapy in a 7-day period. In addition to standard wound care (dressing changes, negative pressure wound therapy, debridement, offloading footwear, glycaemic control and antibiotics, where appropriate).

Extracorporeal shockwave therapy in addition to standard care

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of diabetes mellitus
• Open 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hull

OTHER

Sponsor Role: collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George E Smith, M.D

Role: PRINCIPAL_INVESTIGATOR

Academic Vascular Surgery Unit

Locations

Hull and East Yorkshire Hospitals NHS Trust

Hull, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R2158

Identifier Type: -

Identifier Source: org_study_id