NCT03061461

Radial Extracorporeal Shock Wave Therapy for Chronic Soft Tissue Wounds

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kuala Lumpur General Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound of Skin

Interventions

Type	Name	Description
DEVICE	rESWT	All patients will receive standard care as follows: 1. 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. 2. The clean wounds will be assessed using the TIME concept. 3. Treatment with rESWT. 4. 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".
DEVICE	Sham rESWT	All patients will receive standard care as follows: 1. 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. 2. The clean wounds will be assessed using the TIME concept. 3. Treatment with sham rESWT. 4. 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".

Timeline

• Start date: 2017-02-23
• Primary completion: 2017-12-15
• Completion: 2017-12-15
• First posted: 2017-02-23
• Last updated: 2017-02-24

Locations

1 site across 1 country: Malaysia

Regulatory

• FDA-regulated device study