Short summary

Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain, discomfort and reduced quality of life. The development of foot ulcers places the patients at a risk of amputation. In the Danish Health Care System a substantial effort is done to prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is ongoing. The goal is to optimize wound healing and prevent amputations. In this clinical trial we want to test if ESWT can be used as a treatment for chronic diabetic foot ulcers.

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Rationale

Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A small amount of energy will be deposited in the tissue when shockwaves are applied. This stimulates the cells to produce substances that generate new vessels. Previous studies have shown that ESWT can be used as a treatment for several different conditions e.g. lateral epicondylitis, plantar fasciitis, non-union of long bone, erectile dysfunction and ischemic heart disease. Furthermore, a few studies have shown promising results when treating diabetic foot ulcers with ESWT. In clinical settings, no side effects to ESWT have been shown.

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Description of the cohort

Inclusion criteria:

• Patients diagnosed with a diabetic foot ulcer
• Wagner groups 1 or 2 (ulcer classification)
• Ulcer present for more than 2 months
• Ulcer area over 0,5 cm x 0,5 cm (area over 0,25 cm2)
• Patients read and speak Danish
• Patients deliver informed consent to participate

Exclusion criteria:

• Foot ulcer with a progressive healing
• Vascular surgery performed within the last 2 months
• Wagner groups 2 or 4 (ulcer classification)

Recruitment: 6 months consecutive identification and inclusion of patients in the Wound Clinic, Department of Plastic Surgery OUH. Every year approximately 400 patients with new ulcers are referred to the clinic. Patients who are either newly referred or in advance related to the clinic may be offered participation. Recruitment of a total of between 30 and 60 patients is expected.

Data and biological material

Clinical data, data from the patient medical record, blood samples, swab tests for infection, SF26v2 health survey.

Collaborating researchers and departments

Department of Urology, Odense University Hospital

• Professor and Project Main Supervisor Lars Lund, MD, DMSc

Urological Research Unit, Odense University Hospital

• Undergraduate Research Student Sune Møller Jeppesen

Department of Endocrinology, Odense University Hospital

• Project co-supervisor and PhD-student Benjamin Schnack Rasmussen, MD
• Projects co-supervisor Knud Bonnet Yderstræde, MD, PhD

Wound Clinic, Department of Plastic Surgery Z, Odense University Hospital

Publications associated with the project

Extracorporeal shockwave therapy in the treatment of chronic diabetic foot ulcers: a prospective randomised trial / Jeppesen SM Yderstraede KB, Rasmussen BS, Hanna M, Lund L; J Wound Care. 2016 Nov 2;25(11):641-649.