Radial Extracorporeal Shock Wave Therapy for Chronic Soft Tissue Wounds
Wound of Skin
About this trial
This is an interventional treatment trial for Wound of Skin focused on measuring Extracorporeal shock wave therapy, ESWT, Radial extracorporeal shock wave therapy, rESWT, Diabetes
Eligibility Criteria
Inclusion Criteria:
- adults (both male and female) with chronic soft tissue wounds
- age range: between 18 and 80 years
- willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient
- different kinds of chronic soft tissue wounds: diabetic foot ulcers, post traumatic, venous stasis ulcer, decubitus
- wounds scored as Grade/Stage 1A, 1C, 2A and 2C according to Armstrong et al. (Diabetes Care 1998;21:855-859)
- No contraindications for rESWT
Exclusion Criteria:
- children and teenagers below the age of 18
- no willingness of the patient to participate in the study, and/or written informed consent not signed and not personally dated by the patient
- wounds scored as Grade/Stage 0A, 0B, 0C, 0D, 1B, 1D, 2B, 2D, 3A, 3B, 3C or 3D according to Armstrong et al. (1998)
- Burn wounds
- Uncontrolled diabetes because glycaemic control is crucial for wound healing and erratic values will effect the study results
- Blood sugar levels of the patient before meals are NOT regularly higher than 7mmol/L and are NOT regularly higher than 11mmol/L one to two hours after meals)
- Contraindications of rESWT: treatment of (i) soft tissue wounds over air-filled tissue (lung, gut), (ii) pregnant patients, (iii) patients with blood-clotting disorders (including local thrombosis), (iv) patients treated with oral anticoagulations, (v) soft tissue wounds above local tumors, and (vi) patients treated with local corticosteroid applications in the time period of six weeks before the first rESWT session (if applicable).
Sites / Locations
- Wound Care Unit, Dept. of Internal Medicine, Kuala Lumpur HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
rESWT
Sham rESWT
Treatment of chronic wounds with the Swiss DolorClast (Electro Medical Systems S.A., Nyon, Switzerland) and the EvoBlue handpiece as follows: Use of the 15-mm applicator or the 36-mm applicator of the Swiss DolorClast according to the individual wound size. Six treatment sessions, two treatment sessions per week. 1000 radial shock waves per cm^2 wound and treatment session. Energy flux density 0.07 mJ/mm^2 (i.e., setting of the air pressure of the Swiss DolorClast at 2 bar when using the 15-mm applicator, and at 4 bar when using the 36-mm applicator). Frequency of the radial shock waves set at 15 Hz.
Treatment of chronic wounds with the Swiss DolorClast (Electro Medical Systems S.A., Nyon, Switzerland) and the placebo EvoBlue handpiece of the Swiss DolorClast (that looks and sounds like the EvoBlue handpiece of the Swiss DolorClast, but does not generate radial shock waves) as follows: Use of the 15-mm applicator or the 36-mm applicator of the Swiss DolorClast according to the individual wound size. Six treatment sessions, two treatment sessions per week. 1000 sham radial shock waves per cm^2 wound and treatment session. Energy flux density 0.00 mJ/mm^2 (setting of the air pressure of the Swiss DolorClast at 2 bar when using the 15-mm applicator, and at 4 bar when using the 36-mm applicator). Frequency of the sham radial shock waves set at 15 Hz.