Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

Overview

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.

Full Title of Study: “Extracorporeal Shockwave Therapy for Diabetic Foot Wounds: A Cohort Study Comparing Extracorporeal Shockwave Therapy to Standard Treatment for Diabetic Foot Wounds”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 3, 2019

Interventions

  • 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

Arms, Groups and Cohorts

  • 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).
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hull University Teaching Hospitals NHS Trust
  • Collaborator
    • University of Hull
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • George E Smith, M.D, Principal Investigator, Academic Vascular Surgery Unit

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