Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-01-03 @ 6:47 PM
Study NCT ID:
NCT03061461
Status:
UNKNOWN
Last Update Posted:
2017-02-24
First Post:
2017-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radial Extracorporeal Shock Wave Therapy for Chronic Soft Tissue Wounds
Sponsor:
Kuala Lumpur General Hospital
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: