Hypertrophy; ScarNCT03134053
Effect of Extracorporeal Shock Waves on Hypertrophy Scar
A study testing extracorporeal shock-wave and massage in people with Hypertrophy; Scar, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Assess the effect of extracorporeal shock waves on hypertrophy scar Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertrophy; Scar
- What is being tested?
- extracorporeal shock-wave and massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2017to 1 Jun 2019
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 ~ 65 years old;
- at least 4 weeks since onset of onset of wound;
- healing wound with at least 6 scores in Modified Vancouver Scar Scale for more than four weeks
- the most important of all, read and signed the inform concern of this study.
Who cannot join
- patients with open wound;
- oxygen dependent
- having evidence of cognitive deficit;
- having local infection, severe inflammation or otherwise lesion that is not suggestive for ESWT;
- patient with serious medical problems, as uncontrolled hypertension, coagulopathy, recent severe hemorrhage, neoplasm, severe hepatic disease, epilepsy, cutaneous pathology, mental retardation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Mackay Memorial Hospital
Taipei, 104
Li-Ru Chen, MD, gracealex168@gmail.com
Li-Ru Chen, MD
About this study
Official title: Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar
Assess the effect of extracorporeal shock waves on hypertrophy scar
Read the detailed description
Prolonged and abnormal scarring after trauma, burns and surgical procedures often results in functional and cosmetic deformities. A wide variety of treatments have been advocated for pathologic scars regression. Unfortunately, the reported efficacy has been variable.Unfocused extracorporeal shock wave therapy is a feasible and non-intensive treatment. And it is an emerging option for the treatment of painful and retracting scars.
Administration of ESWT appears to result in significant improvements in scar clinical appearance, mobility and subjective pain. Clinical data were mirrored by histologic changes in connective tissue appearance and scar vascularization. Extracorporeal shock wave therapy is also an effective and conservative treatment for patients with aesthetic and functional sequela from burn scars. It is a feasible, cost-effective, well-tolerated treatment that can be used in the management of post-burn pathologic scars after the patients are briefed on the practical aspects of the treatment procedure.
- Conditions
- Hypertrophy; Scar
- Being tested
- extracorporeal shock-wave, massage
- Keywords
- hypertrophy scar, burn
- Medical subject headings
- Cicatrix, Hypertrophic, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shock-waveDevice
to treat painful and retracting scars
massageOther
to treat painful and retracting scars
| Study group | Role | What they receive |
|---|---|---|
| extracorporeal shock-wave | Experimental | Not described Receives: Device: extracorporeal shock-wave |
| massage | Sham comparator | Not described Receives: Other: massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline thick of scar
sonography for thick of scar
Measured: immediately post intervention, 1 month after, and 3 months
Secondary outcomes (4)
change from baseline Modified Vancouver Scar Scale
questionnaires of Modified Vancouver Scar Scale for scar measure
Measured: immediately post intervention, 1 month after, and 3 months
change from baseline Visual analogue scores (VAS)
Visual analogue scores (VAS) for pain
Measured: immediately post intervention, 1 month after, and 3 months
change from baseline skin color
DermaLab Combo series for skin color
Measured: immediately post intervention, 1 month after, and 3 months
change from baseline Patient Scar Assessment Scale (POSAS)
questionnaires of Patient Scar Assessment Scale (POSAS) for scar measure
Measured: immediately post intervention, 1 month after, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophy; ScarStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Ru Chen,MD, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134053
- Sponsor's protocol ID
- 16MMHIS025e
- Status last verified
- Aug 2017
- First submitted
- 19 Apr 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar
- ClinicalTrials.gov ID
- NCT03134053
- Acronym / sponsor ID
- 16MMHIS025e
- Conditions
- Hypertrophy; Scar
- Keywords
- hypertrophy scar, burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 28 Apr 2017 (actual)
- 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.
Assess the effect of extracorporeal shock waves on hypertrophy scar
Detailed description
Prolonged and abnormal scarring after trauma, burns and surgical procedures often results in functional and cosmetic deformities. A wide variety of treatments have been advocated for pathologic scars regression. Unfortunately, the reported efficacy has been variable.Unfocused extracorporeal shock wave therapy is a feasible and non-intensive treatment. And it is an emerging option for the treatment of painful and retracting scars.
Administration of ESWT appears to result in significant improvements in scar clinical appearance, mobility and subjective pain. Clinical data were mirrored by histologic changes in connective tissue appearance and scar vascularization. Extracorporeal shock wave therapy is also an effective and conservative treatment for patients with aesthetic and functional sequela from burn scars. It is a feasible, cost-effective, well-tolerated treatment that can be used in the management of post-burn pathologic scars after the patients are briefed on the practical aspects of the treatment procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extracorporeal shock-wave | Experimental | Device: extracorporeal shock-wave |
| massage | Sham comparator | Other: massage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged between 18 ~ 65 years old;
- at least 4 weeks since onset of onset of wound;
- healing wound with at least 6 scores in Modified Vancouver Scar Scale for more than four weeks
- the most important of all, read and signed the inform concern of this study.
Key exclusion criteria (5 listed)
- patients with open wound;
- oxygen dependent
- having evidence of cognitive deficit;
- having local infection, severe inflammation or otherwise lesion that is not suggestive for ESWT;
- patient with serious medical problems, as uncontrolled hypertension, coagulopathy, recent severe hemorrhage, neoplasm, severe hepatic disease, epilepsy, cutaneous pathology, mental retardation.
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 shock-waveto treat painful and retracting scars | Device | extracorporeal shock-wave |
| massageto treat painful and retracting scars | Other | massage |
Primary outcome
change from baseline thick of scar
Time frame: immediately post intervention, 1 month after, and 3 months
sonography for thick of scar
4 secondary outcomes
change from baseline Modified Vancouver Scar Scale
Time frame: immediately post intervention, 1 month after, and 3 months
change from baseline Visual analogue scores (VAS)
Time frame: immediately post intervention, 1 month after, and 3 months
change from baseline skin color
Time frame: immediately post intervention, 1 month after, and 3 months
change from baseline Patient Scar Assessment Scale (POSAS)
Time frame: immediately post intervention, 1 month after, and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal shock-wave and massage in people with Hypertrophy; Scar, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Aug 2017. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Ru Chen, MD (886-2-2543-3535, gracealex168@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline thick of scar (time frame: immediately post intervention, 1 month after, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2017.