Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

NCT04042285 | Completed Results

• 1 other identifier: R2158
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Diabetic Foot Wound

Outcome Measures

Primary Outcomes (1)

• Wound Volume

  Change in wound volume between study visits

  12 weeks

Secondary Outcomes (7)

• Pain Questionnaire

  12 weeks

• Quality of Life Questionnaires SF-12

  12 weeks

• Infection Rate

  Recorded at 12 weeks

• Minor Amputation Rate

  Recorded at 12 weeks

• Local Perfusion Rate

  7 days

Study Arms (1)

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).

Device: Extracorporeal shockwave therapy in addition to standard care

Interventions

Extracorporeal shockwave therapy in addition to standard care 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.

Extracorporeal shockwave therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients with a foot wound

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Hull and East Yorkshire Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot; Wounds and Injuries

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Louise Hitchman
• Organization: Hull University Teaching Hospitals NHS Trust

l.hitchman@nhs.net

01482 311925

Study Officials

• George E Smith, M.D

  Academic Vascular Surgery Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: August 1, 2019
• Study Start: February 1, 2019
• Primary Completion: February 2, 2020
• Study Completion: May 13, 2022
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)