None listed
Conditions
Brief summary
Diabetic foot ulcer (DFU) is a common complication of diabetes with high rates for ulcer recurrence. We hypothesize that monthly Extracorporeal shockwave therapy (ESWT) and Electromagnetic stimulation therapy (EMST) will reduce the ulcer recurrence rates compared to the standard of care in a 12 month period.. We aim to test the hypothesis by determining the effect of monthly treatment on ulcer recurrence using Extracorporeal shockwave therapy (ESWT) and Electromagnetic stimulation therapy (EMST) along with standard of care and compared against standard of care in a 12 month randomized clinical trial.
Interventions
This study is a 12 Month single-centre, two-campus, randomized, -controlled clinical trial to compare Extracorporeal shock wave therapy (ESWT) + standard of care (SOC) or electromagnetic stimulator therapy (EMST) + SOC as intervention arm.
The ESWT treatment will be delivered at the Townsville university hospital or any approved sites by a by a experienced podiatrist in administering the treatment. The treatment will start with slow delivery of the shockwave impulses into the area of wound si
This study is a 12 Month single-centre, two-campus, randomized, -controlled clinical trial to compare Extracorporeal shock wave therapy (ESWT) + standard of care (SOC) or electromagnetic stimulator therapy (EMST) + SOC as intervention arm. The ESWT treatment will be delivered at the Townsville university hospital or any approved sites by a by a experienced podiatrist in administering the treatment. The treatment will start with slow delivery of the shockwave impulses into the area of wound site, until the patient is accustomed to the nature of the treatment. Then, the ESWT impulses of 300 + 100/cm2 will be applied at 0.11 mJ/cm2 energy flux density evenly applied to foot/calves bilaterally every month for 12 months. The whole treatment session will take up to 30 minutes/participant. The EMST will be delivered at the Townsville university hospital or any approved sites by a by a experienced podiatrist in administering the treatment. The treatment will be delivery of electromagnetic stimulation therapy of 150 V, 100 µs, 100 Hz, lasting 45 minutes will be applied to the ulcer surface once every month for a total of twelve treatments.
Sponsors
Townsville University Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult subjects greater than or equal to 18 years with a history of diabetic foot ulcers (DFUs) who consented will be included in the study. Both sexes will be enrolled.
Exclusion criteria
1. Patients with any of the following: coronary bypass, pregnancy, coagulation diseases, or history of neoplasia or other conditions based on the Principal Investigator's clinical judgment 2. Subjects with artificial joints with metallic objects 3. Patient with a pacemaker or implantable defibrillators. 4. Participation in any other clinical trial. 5. Inability to comply with study protocol.
Outcome results
None listed