Chronic Nonhealing WoundsPhase 2NCT00545896
Extracorporeal Shockwave Treatment for Chronic Soft Tissue Wounds
A Phase 2 study testing Extracorporeal shockwave therapy in people with Chronic Nonhealing Wounds, run by AUVA at 1 site in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Nonhealing Wounds
- What is being tested?
- Extracorporeal shockwave therapy
- Type of treatment
- Surgery or procedure
- How many people
- 282 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2003to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a chronic soft tissue wound persisting for longer than one month.
- Cause of chronic wound irrelevant except circumferential second degree burn wounds of upper/lower extremity.
- Capable of wound care at home or home nursing available.
- Patients older than 18 years.
- The patient is willing, able to read, understand and willing to give informed consent to the study procedure.
- Female patients will not be pregnant.
- The patient will agree to an outpatient clinic treatment.
- The patient agrees to comply with the protocol requirements, including the self care of wounds and all follow up visit requirements
Who cannot join
- Pregnancy
- Active or previous (within 8 weeks to the study screening visit) chemotherapy
- Deep vein thrombosis within 6 months to the study screening visit
- Lower extremity revascularization procedure (e. g. PTA, graft or other) within 8 weeks to the study screening visit
- Current history of substance abuse
- Physical or mental disability ( if not cared for, i. e. home nursing etc)or geographical concerns (residence not within reasonable travel distance to study center)that would hamper compliance with required study visits
- Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 8 weeks to the study screening visit
- The investigator believes that the subject will be unwilling or unable to comply with the study protocol requirements, including the ESWT procedure, standard of care self-care requirements and all study related follow-up visit requirements.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Unfallkrankenhaus Meidling - Trauma Center Meidling
Vienna, 1120
About this study
Official title: Safety and Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Chronic Soft Tissue Wounds
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.
Read more
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.
- Conditions
- Chronic Nonhealing Wounds
- Being tested
- Extracorporeal shockwave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave therapyProcedure or surgery
Extracorporeal application of shockwaves on the surface of chronic wounds.
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 30 days after last ESWT session
Secondary outcomes (1)
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.
Measured: 30 days after last ESWT session or drop out date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startSep 2003
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Nonhealing WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUVA
- Sponsor type
- University, hospital or other
- Investigators
- Klaus S. WOLFF, MD, Principal investigator, Heeresspital - Wien - Austrian Armed Forces Hospital - Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545896
- Sponsor's protocol ID
- ESWT 001 - 2003
- Status last verified
- Aug 2009
- First submitted
- 16 Oct 2007
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolff KS, Wibmer A, Pusch M, Prusa AM, Pretterklieber M, Teufelsbauer H, Schaden W. The influence of comorbidities and etiologies on the success of extracorporeal shock wave therapy for chronic soft tissue wounds: midterm results. Ultrasound Med Biol. 2011 Jul;37(7):1111-9. doi: 10.1016/j.ultrasmedbio.2011.04.007. Epub 2011 Jun 2.
PubMed 21640475
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Chronic Soft Tissue Wounds
- ClinicalTrials.gov ID
- NCT00545896
- Acronym / sponsor ID
- ESWT 001 - 2003
- Conditions
- Chronic Nonhealing Wounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- AUVAUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of a chronic soft tissue wound persisting for longer than one month.
- Cause of chronic wound irrelevant except circumferential second degree burn wounds of upper/lower extremity.
- Capable of wound care at home or home nursing available.
- Patients older than 18 years.
- The patient is willing, able to read, understand and willing to give informed consent to the study procedure.
Key exclusion criteria (8 listed)
- Pregnancy
- Active or previous (within 8 weeks to the study screening visit) chemotherapy
- Deep vein thrombosis within 6 months to the study screening visit
- Lower extremity revascularization procedure (e. g. PTA, graft or other) within 8 weeks to the study screening visit
- Current history of substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shockwave therapyExtracorporeal application of shockwaves on the surface of chronic wounds. | Procedure or surgery | – |
Primary outcome
All cause mortality
Time frame: 30 days after last ESWT session
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
- Results publication: PubMed 21640475Wolff KS, Wibmer A, Pusch M, Prusa AM, Pretterklieber M, Teufelsbauer H, Schaden W. The influence of comorbidities and etiologies on the success of extracorporeal shock wave therapy for chronic soft tissue wounds: midterm results. Ultrasound Med Biol. 2011 Jul;37(7):1111-9. doi: 10.1016/j.ultrasmedbio.2011.04.007. Epub 2011 Jun 2.
Related trials for Chronic Nonhealing Wounds
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus S. WOLFF, MD principal investigator
Heeresspital - Wien - Austrian Armed Forces Hospital - Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extracorporeal shockwave therapy in people with Chronic Nonhealing Wounds, run by AUVA at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 30 days after last ESWT session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00545896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2011.