Radial Extracorporeal Shock Wave Therapy for Chronic Soft Tissue Wounds

Study Overview
=================
Brief Summary
-----------------
This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) as performed by Zoech (JATROS Orthop 2009;(1):46-47) is effective and safe in treatment of chronic soft tissue wounds, and is statistically significantly more effective than sham-treatment of chronic soft tissue wounds.

Detailed Description
-----------------
Zoech (2009) treated in a feasibility study a total of n=18 patients affected by 21 ulcers in Stage IA or IIA (according to Armstrong and colleagues, Diabetes Care 1998;21:855-859) with repetitive radial extracorporeal shock wave therapy (rESWT) using the Swiss DolorClast device (Electro Medical Systems S.A., Nyon, Switzerland). The wounds had been observed for more than 6 weeks. In nine cases the wounds were located in non-loaded areas such as the edge of the foot, or appeared after previous toe amputation. In 12 cases the wounds were located on the sole, the toes or the heel; in these cases the average area of the wounds was 351 mm^2 (116 to 599 mm^2). Local wound treatment consisted of regular debridement by scalpel, followed by disinfection with sterile saline solution and application of wet treatment adequate to the stage of the wounds. Depending on the amount of secretion, the depth of the ulcer and the healing stages, different bandage materials were used. Besides this, rESWT was applied at intervals depending on the size and the depth of the ulcers, once or twice a week for three to six weeks, with 1,000 impulses per cm^2 and treatment session with positive energy flux density (EFD) of 0.1 mJ/mm^2. To this end ulcers were covered with sterile drape in order to avoid direct contact of ultrasound jelly and the handpiece of the rESWT device with the ulcers. After further disinfection with sterile saline solution, bandage was applied. The state of the ulcers was documented photographically at regular intervals and the size of the ulcers were evaluated with digital image analysis. Wounds were evaluated after the first, second and third week. Zoech (2009) noted that rESWT caused no pain, and neither local or generalized infections were observed throughout the observation period. Sixteen out of the 21 wounds healed within a mean period of six weeks (range: 3 to 9 weeks). In three cases, sufficient granulation tissue was formed after eight weeks on average, allowing for wound covering by gap tissue transplant. On average the size of the ulcers was reduced to 67% (20-100%) after the first week, 53% (15-90%) after the second week and 35% (9-78%) after the third week compared to baseline. These data indicate that the application of repetitive rESWT using the Swiss DolorClast is a low-effort and effective complement to standard therapy in diabetic foot ulcers without signs of infection or ischemia. In the study by Zoech (2009) patients were specifically very satisfied by the good tolerability and the absence of any significant side effects. However, Zoech (2009) did not investigate a control group. Accordingly, it is currently unknown whether rESWT as performed by Zoech (2009) is more effective than sham-treatment of chronic soft tissue wounds. The present study was designed to answer this question.

Official Title
-----------------
A Prospective, Randomized, Double-blind, Placebo Controlled, Parallel Group, Single Center Trial to Assess the Efficacy and Safety of Radial Extracorporeal Shock Wave Therapy in Subjects With Chronic Soft Tissue Wounds

Conditions
-----------------
Wound of Skin

Intervention / Treatment
-----------------
* Device: rESWT
* Device: Sham rESWT


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized controlled trial (RCT), no blinding of therapists applying the treatments, blinding of patients, blinding of evaluators. Partial cross-over design: patients in the control group will be offered to be treated with rESWT starting three months after the last sham treatment. This will guarantee that every patient will receive a real rESWT treatment independent of blind allocation to one of the treatment groups.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rESWT<br>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. | Device: rESWT<br>* All patients will receive standard care as follows: Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee. The clean wounds will be assessed using the TIME concept. Treatment with rESWT. Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin, Smith & Nephew, Inc. Advanced Wound Management; Fort Worth, TX, USA). In addition, patients in arm rESWT will receive rESWT between Steps 2 and 3 of standard care as outlined in arm description rESWT.<br>|
| Sham Comparator: Sham rESWT<br>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. | Device: Sham rESWT<br>* All patients will receive standard care as follows: Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee. The clean wounds will be assessed using the TIME concept. Treatment with sham rESWT. Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin). In addition, patients in arm Sham rESWT will receive sham rESWT between Steps 2 and 3 of standard care as outlined in arm description Sham rESWT.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound size | Individual time necessary to convert a chronic soft tissue wound from Grade/Stage 1A, 1C, 2A or 2C according to Armstrong et al. (Diabetes Care 1998;21:855-859) into Grade/Stage 0A or 0C according to Armstrong et al. (1998) (i.e., lesion completely epithelialized). | Three months after start of the treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort during treatment | Individual patient's comfort during treatment will be assessed using a scale ranging from 0 (maximum discomfort) to 10 (maximum comfort). | Immediately after each treatment session | 
| Pain intensity during treatment | Individual patient's pain during treatment will be assessed using a scale ranging from 0 (no pain at all) to 10 (maximum, unbearable pain). | Immediately after each treatment session | 
| Satisfaction | Individual patient's satisfaction at three months after the start of the treatments will be assessed using a scale ranging from 0 (maximum dissatisfaction) to 10 (maximum satisfaction). | Three months after start of the treatments | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal shock wave therapy, ESWT, Radial extracorporeal shock wave therapy, rESWT, Diabetes