Cicatrix, HypertrophicNCT04558944
The Effect of Extracorporeal Shock Wave Therapy in the Treatment of Post Burn Scars
A study testing Extracorporal Shock Wave Therapy in people with Cicatrix, Hypertrophic, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
A prospective, randomized, controlled study. The patients were divided into two groups with twenty patients per group. The control group received the standard treatment for postburn scars. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cicatrix, Hypertrophic
- What is being tested?
- Extracorporal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2017to 15 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypertrophic post burn scars of approximately 64 cm2 surface area.
Who cannot join
- Patients younger than 18 year.
- Pregnant women.
- Having a known skin condition (e.g. psoriasis, skin cancer etc.).
- Immunosuppression.
- Hemophilia .
- Matured scars.
- Scars located above the lungs, the bowels, the gonads or electronic implants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Use of the Extracorporeal Shock Wave Therapy in the Treatment of Pathological Post Burn Scars
A prospective, randomized, controlled study. The patients were divided into two groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group received the standard treatment and treatment of postburn scars with Extracorporeal Shock Wave Therapy 512 impulses of 0.15mJ/mm 2 in each session, twice per week for 4 weeks.
The investigators assessed the appearance of scar with the Vancouver Scar Scale (VSS), pruritus and pain with Visual Analog Scale (VAS) before the start of the treatment and at 2 weeks and 5 months after the treatment.
- Conditions
- Cicatrix, Hypertrophic
- Being tested
- Extracorporal Shock Wave Therapy
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporal Shock Wave TherapyDevice
Acoustic high amplitude waves with Energy Flux Density of 0.15mJ/mm 2 and 512 pulses per session. A total of two sessions per week during a 4-week period.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This group received pain and pruritus medication as needed, received the usual physical therapy as per the protocol of our burn unit, as well as compression garments, silicone sheets and gels and moisturizing cream twice a day. Additionally, the patients were advice on reducing sun exposure and applying +50SPF sunblock on a daily basis. |
| Extracorporeal Shock Wave Therapy group | Experimental | This group received the same treatment as the control group plus Extracorporeal Shock Wave Therapy (The DermaPACE® System, SANUWAVE Health Inc., USA) with Energy Flux Density of 0.15mJ/mm 2 and 512 pulses per session. A total of two sessions per week during a 4-week period. Receives: Device: Extracorporal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar appearance
Scar appearance by Vancouver Scar Scale. Minimum value 0. Maximum value 13. Higher scores mean a worse outcome.
Measured: 6 months from inclusion
Secondary outcomes (2)
Scar pruritus
Pruritus measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.
Measured: 6 months from inclusion
Scar pain
Pain measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.
Measured: 6 months from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Jan 2017
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cicatrix, HypertrophicStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Model description
- Two randomized groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group (ESWT) received the standard treatment and treatment of postburn scars with ESWT 512 impulses of o.15mJ/mm 2 in each session, twice per week for 4 weeks.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558944
- Sponsor's protocol ID
- PR(ATR)398/2016
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of the Extracorporeal Shock Wave Therapy in the Treatment of Pathological Post Burn Scars
- ClinicalTrials.gov ID
- NCT04558944
- Acronym / sponsor ID
- PR(ATR)398/2016
- Conditions
- Cicatrix, Hypertrophic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 22 Sep 2020 (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.
A prospective, randomized, controlled study. The patients were divided into two groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group received the standard treatment and treatment of postburn scars with Extracorporeal Shock Wave Therapy 512 impulses of 0.15mJ/mm 2 in each session, twice per week for 4 weeks.
The investigators assessed the appearance of scar with the Vancouver Scar Scale (VSS), pruritus and pain with Visual Analog Scale (VAS) before the start of the treatment and at 2 weeks and 5 months after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two randomized groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group (ESWT) received the standard treatment and treatment of postburn scars with ESWT 512 impulses of o.15mJ/mm 2 in each session, twice per week for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This group received pain and pruritus medication as needed, received the usual physical therapy as per the protocol of our burn unit, as well as compression garments, silicone sheets and gels and moisturizing cream twice a day. Additionally, the patients were advice on reducing sun exposure and applying +50SPF sunblock on a daily basis. |
| Extracorporeal Shock Wave Therapy group | Experimental | Device: Extracorporal Shock Wave TherapyThis group received the same treatment as the control group plus Extracorporeal Shock Wave Therapy (The DermaPACE® System, SANUWAVE Health Inc., USA) with Energy Flux Density of 0.15mJ/mm 2 and 512 pulses per session. A total of two sessions per week during a 4-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with hypertrophic post burn scars of approximately 64 cm2 surface area.
Key exclusion criteria (7 listed)
- Patients younger than 18 year.
- Pregnant women.
- Having a known skin condition (e.g. psoriasis, skin cancer etc.).
- Immunosuppression.
- Hemophilia .
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 |
|---|---|---|
| Extracorporal Shock Wave TherapyAcoustic high amplitude waves with Energy Flux Density of 0.15mJ/mm 2 and 512 pulses per session. A total of two sessions per week during a 4-week period. | Device | Extracorporeal Shock Wave Therapy group |
Primary outcome
Scar appearance
Time frame: 6 months from inclusion
Scar appearance by Vancouver Scar Scale. Minimum value 0. Maximum value 13. Higher scores mean a worse outcome.
2 secondary outcomes
Scar pruritus
Time frame: 6 months from inclusion
Scar pain
Time frame: 6 months from inclusion
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 1 Oct 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporal Shock Wave Therapy in people with Cicatrix, Hypertrophic, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 1 inclusion and 7 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 1 Oct 2020. 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 Spain. 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.
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?
Scar appearance (time frame: 6 months from inclusion). 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 1 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.