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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Foot; Wound
• Intervention / Treatment: Device: Extracorporeal shockwave therapy; Other: Standard Wound Care

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hull, United Kingdom, HU3 2JZ
    • Hull and East Yorkshire Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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; 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.
Placebo Comparator: Standard wound care; Patient with a diabetic foot wound who receive standard wound care, consisting of dressing changes, negative pressure wound therapy, debridement, offloading footwear, glycaemic control and antibiotics, where appropriate.	Other: Standard Wound Care; dressing changes, negative pressure wound therapy, offloading footwear, debridement, glycaemic control and antibiotics as necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound volume	Change in wound volume between study visits	Baseline, up to 7 days, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Collaborators: University of Hull
• Investigators: Principal Investigator: George E Smith, M.D, Academic Vascular Surgery Unit

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): December 3, 2019
• Study Completion (Anticipated): May 20, 2022

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Diabetic Foot Wound
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot; Wounds and Injuries
• Other Study ID Numbers: R2158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No