Extracorporeal Shockwave Treatment for Chronic Soft Tissue Wounds
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|ClinicalTrials.gov Identifier: NCT00545896|
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : July 18, 2011
Chronic soft tissue wounds represent a difficult problem for patients and doctors as well. Chronic wounds can be caused by internal and dermatological diseases like venous ulcers as a consequence of venous insufficiency, arterial ulcers as a consequence of peripheral occlusive vascular disease, the diabetic foot stemming from diabetes and other pathologies. A different reason for chronic wounds could be prior traumatic injuries (war wounds, traffic accidents)not showing a tendency to heal after surgical repair.
The primary goal in the treatment of chronic soft tissue wounds is to obtain wound closure. Usually necrotic tissue is debrided, i.e. surgically removed, to assess the full extent of the damage, to detect underlying abscesses or other pathologies causing the non-healing of the wound. Wet - to - wet dressings are primarily applied to induce a healing process. As second line attempts to obtain closure special dressings like semipermeable films, gels, hydrocolloids and calcium alginates are applied. These expensive dressings are associated with extended time periods of conservative treatment until closure can be observed.
A third line after failure of nonoperative treatment is the application of skin graft. This involves the operative and anesthesiological risk for an already health wise compromised patient with little to no physiological reserve. One should not forget that the majority of patients presenting at outpatient clinics with chronic soft tissue wounds are the elderly with/without disabling comorbidities.
The use of extracorporeal shockwaves (ESW) for clinical applications was introduced in central Europe more than two decades ago. Extracorporeal shockwave therapy (ESWT)is used in the fields of urology, orthopedic surgery, trauma surgery. ESW are associated with the induction of neovascularisation and with mechanical stimuli causing proliferation of a large number of cells including osteoblasts (Martini L., J Trauma 2006). The exact effects of ESW on human cells are currently studied in several centers worldwide. The application of ESWT in the above mentioned fields of medicine proved safe, reliable and almost complication-free.
Our center's experience with ESWT in trauma surgery (Schaden W., Clin. Orthop 2001)and the observation that not only the traumatic condition (fracture non-union, etc.), but also the surrounding tissue showed favorable tissue healing after ESWT, leads to our hypothesis that ESWT might be beneficial for the much larger number of chronic soft tissue wounds. The investigators anticipate to induce complete wound healing in a number of defined clinical/pathological conditions by ESWT. At the same time efficacy and safety of ESWT will be investigated.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Nonhealing Wounds||Procedure: Extracorporeal shockwave therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||282 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Chronic Soft Tissue Wounds|
|Study Start Date :||September 2003|
|Primary Completion Date :||June 2010|
|Study Completion Date :||September 2010|
Procedure: Extracorporeal shockwave therapy
- All cause mortality [ Time Frame: 30 days after last ESWT session ]
- Rate of complete wound closure and number of ESWT sessions needed. Rate of nonhealing wounds and number of ESWT sessions until drop out/ reasons for drop out. [ Time Frame: 30 days after last ESWT session or drop out date. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545896
|Unfallkrankenhaus Meidling - Trauma Center Meidling|
|Wien, Austria, 1120|
|Principal Investigator:||Klaus S. WOLFF, MD||Heeresspital - Wien - Austrian Armed Forces Hospital - Vienna|