Hypertrophic ScarNCT06803472
Pulsed High Intensity Laser Versus Extracorporeal Shockwave Therapy on Hypertrophic Scar Post Burn
A study testing pulsed high intensity laser therapy and Extracorporeal shockwave therapy in people with Hypertrophic Scar, run by Cairo University.
Trial summary
The goal of this clinical trial stydy : is to compare between the effect of pulsed high intensity laser and extracorporeal shockwave therapy on hypertrophic scar on post burned patients. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- pulsed high intensity laser therapy and Extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2025to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patients age will range from 20 to 45 years.
- All patients will be free from any other pathological conditions or histories except hypertrophic scar.
- patients will be selected from both gender.
- All patients will have hypertrophic scars post burn injuries.
Who cannot join
- The patients who have open wound at or near treatment site.
- The patients who have cardiac pacemakers or other implanted electronic devices.
- The patients who have any significant health problem such as diabetes, circulatory
- disorders or history of skin malignancy in the treated area.
- uncooperative patients.
- The patients who have a deep venous thrombosis (DVT).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Haidy Nady Ashem, professor contact
About this study
The goal of this clinical trial stydy : is to compare between the effect of pulsed high intensity laser and extracorporeal shockwave therapy on hypertrophic scar on post burned patients.
The main questions is it aims to answer is :
- Which is more effective on hypertrophic scar post burn Extracorporeal shockwave therapy or pulsed high intensity laser therapy?
- Participants will receive the treatment for 6 weeks.
- Assesment will be don before and after treatment.
Read the detailed description
- Subjects : Sixty patients have hypertrophic scar post burn. They will be selected from El Gamaa hospital and randomly distributed into two equal groups. Their ages will be ranged from 20 to 45 years.
- Design of the study :
In this study, the patients will be randomly divided into two equal groups in number (30 patients each).
- Group A (pulsed high intensity laser group): In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive pulsed high intensity laser in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be three times per week.
- Group B (Extracorporeal shockwave group):
In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive Extracorporeal shockwave therapy in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be two times per week.
Equipments :
.Measurement equipments :
- Modified Vancouver burn Scar assessment scale : Modified Vancouver scar scale (VSS), an observer-dependent scale of the macroscopic appearance of scarring, was used to measure changes in the scar over the period of treatment. The Modified Vancouver Scar Scale score is probably the most widely known scar scale that consists of three components (vascularization, pliability and scar height); the total score ranges from 0 to 11, with 0 representing normal skin.To assess 3 variables of scar characteristics: Vascularity, pliability and height. Scoring; vascularity ranged from 0 to 3 (1 Pink, 2 Red, 3 Purple), pliability ranged from 0 to 5 (1 Supple, 2 Yielding, 3 Firm, 4 Ropes, 5 Contracture) and height ranged from 0 to 3 (1 Less than 2 mm, 2 From 2 to 5 mm, 3 More than 5 mm). The larger the total score, the worse the HTS. The investigators choose an algebraic value for any of these characteristics based on a comparison with normal skin (zero score)
- A Schiotz tonometer scale :
This scale will be used as an objective scale to asses the hypertrophic scar pliability and elasticity.
The tissue tonometer provides a repeatable and objective index of burn scar pliability. it is a simple, clinically useful technique for monitoring an individual's scar.
To assess scar pliability and elasticity improvement by an objective manner It is held vertically at a measured point of the scar, so the plunger moved downwards by gravity and indent the scar tissue. The instrument gives a reading on a horizontal scale numbered arbitrarily from 0 to 20, but the device does not measure scar pressure directly, a conversion table, supplied with the Schiotz tonometer pressure directly, a conversion table, supplied with the Schiotz tonometer, is used to translate the instrument readings into measurements by mmHg .
Treatment procedure :
- Pulsed High Intensity Laser application procedure:
- Should wear laser-protective glasses or goggles.
- Inappropriate use of the goggles is more dangerous than their non-use, as they may provide a false sense of security.
- Laser equipment should be placed in a controlled area with minimal access to avoid inadvertent exposure.
- Avoid laser reflection from mirrored surfaces.
- Avoid exposure of eyes, unclosed fontanels of children.
- Applied at at fluence of 40 J/cm2 , pulse duration of 0.3 m/s , spot size of 5 mm in a focused mode for 3 passes.
- Extracorporeal shockwave application procedure:
- Patients will receive sessions of ESWT twice a week for 6 weeks.
- ESWT will be administered on an outpatient basis; the selected treatment area is usually the most uncomfortable for the patient. Patient placed into comfortable position that allowed the vision of the treated area.
- Each treatment region covered with 2500 to 3000 impulses with average session time 10-15 min. conservative treatment for both groups: (Stretching exercises and Deep friction massage ) 2 sessions per week for 6 weeks
- Conditions
- Hypertrophic Scar
- Being tested
- pulsed high intensity laser therapy, Extracorporeal shockwave therapy
- Keywords
- Hypertrophic scar
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed high intensity laser therapyDevice
The high-intensity laser therapy (HILT), which involves laser radiation with high-intensity, is a kind of novel and powerful . The HILT possesses its own photomechanical, photothermal, and the photo-chemical properties.
Extracorporeal shockwave therapyDevice
Extracorporeal shockwave therapy is an acoustic wave that mechanically disrupts tissue by cavitation.Shock waves develop microscopic injuries in scar tissue and break down collagen fibers which lead to scar remodelin .The patient is positioned in a comfortable position. The scar site is prepared with contact gel to conduct the shock waves, 30-50 shocks/cm2 , with an energy flux density of 0.25mJ/mm2 and a frequency of 6Hz. Each treatment region is covered with 2500 to 3000 impulses with an average session time of 10-15min .
| Study group | Role | What they receive |
|---|---|---|
| study group receives pulsed high intensity laser and coservative treatment | Active comparator | Not described Receives: Device: pulsed high intensity laser therapy |
| study group receives extracorporeal shockwave therapy and coservative treatment | Active comparator | Not described Receives: Device: Extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Vancouver burn Scar assessment scale
Modified Vancouver scar scale , an observer-dependent scale of the macroscopic appearance of scarring, is used to measure changes in the scar over the period of treatment,The Modified Vancouver Scar Scale score is probably the most widely known scar scale that consists of three components (vascularization, pliability and scar height); the total score ranges from 0 to 11, with 0 representing normal skin ,Scoring; vascularity ranged from 0 to 3 (1 Pink, 2 Red, 3 Purple), pliability ranged from 0 to 5 (1 Supple, 2 Yielding, 3 Firm, 4 Ropes, 5 Contracture) and height ranged from 0 to 3 (1 Less than 2 mm, 2 From 2 to 5 mm, 3 More than 5 mm). The larger the total score, the worse the HTS. The investigators choose an algebraic value for any of these characteristics based on a comparison with normal skin (zero score).
Measured: change of the total score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)
Secondary outcomes (1)
Aschiotz tonometer device
Aschiotz tonometer device, will be used as an objective scale to asses the hypertrophic scar pliability and elasticity.
The tissue tonometer provides a repeatable and objective index of burn scar pliability. it is a simple, clinically useful technique for monitoring an individual's scar It is held vertically at a measured point of the scar, so the plunger moved downwards by gravity and indent the scar tissue. The instrument gives a reading on a horizontal scale numbered arbitrarily from 0 to 20, but the device does not measure scar pressure directly, a conversion table, supplied with the Schiotz tonometer, is used to translate the instrument readings into measurements by mmHg.
Measured: change of the hypertrohic scar pressure score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start26 Jan 2025 (estimated)
- Primary completion10 Feb 2025 (estimated)
- Study completion25 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Group A (30 patients receive pulsed high intensity laser plus taditional PT treatment for postburn hypertrophic scar. Groyp B (30 patients recaive extracorporeal shockwave therapy plus traditional PT treatment for post burn hypertrophic scar.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Fayed Ali Ibrahim, Cairo University
- Investigators
- Haidy Nady Ashem, professor, Study director, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803472
- Sponsor's protocol ID
- P.T.REC/012/004524
- Status last verified
- Dec 2024
- First submitted
- 26 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruchiatan K, Suhada KU, Hindritiani R, Puspitosari D, Septrina R. Combination of 1064 nm Long-Pulsed and Q-Switched Nd:YAG Laser for Facial Hypertrophic Scar and Hyperpigmentation Following Burn Injury. Int Med Case Rep J. 2022 Jan 25;15:23-27. doi: 10.2147/IMCRJ.S348091. eCollection 2022.
PubMed 35115845Lee SY, Joo SY, Cho YS, Hur GY, Seo CH. Effect of extracorporeal shock wave therapy for burn scar regeneration: A prospective, randomized, double-blinded study. Burns. 2021 Jun;47(4):821-827. doi: 10.1016/j.burns.2020.08.009. Epub 2020 Aug 29.
PubMed 32917473
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed High Intensity Laser Versus Extracorporeal Shockwave Therapy on Hypertrophic Scar Post Burn
- ClinicalTrials.gov ID
- NCT06803472
- Acronym / sponsor ID
- P.T.REC/012/004524
- Conditions
- Hypertrophic Scar
- Keywords
- Hypertrophic scar
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Jan 2025 (estimated)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 25 Mar 2025 (estimated)
- First posted
- 31 Jan 2025 (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.
The goal of this clinical trial stydy : is to compare between the effect of pulsed high intensity laser and extracorporeal shockwave therapy on hypertrophic scar on post burned patients.
The main questions is it aims to answer is :
- Which is more effective on hypertrophic scar post burn Extracorporeal shockwave therapy or pulsed high intensity laser therapy?
- Participants will receive the treatment for 6 weeks.
- Assesment will be don before and after treatment.
Detailed description
- Subjects : Sixty patients have hypertrophic scar post burn. They will be selected from El Gamaa hospital and randomly distributed into two equal groups. Their ages will be ranged from 20 to 45 years.
- Design of the study :
In this study, the patients will be randomly divided into two equal groups in number (30 patients each).
- Group A (pulsed high intensity laser group): In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive pulsed high intensity laser in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be three times per week.
- Group B (Extracorporeal shockwave group):
In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive Extracorporeal shockwave therapy in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be two times per week.
Equipments :
.Measurement equipments :
- Modified Vancouver burn Scar assessment scale : Modified Vancouver scar scale (VSS), an observer-dependent scale of the macroscopic appearance of scarring, was used to measure changes in the scar over the period of treatment. The Modified Vancouver Scar Scale score is probably the most widely known scar scale that consists of three components (vascularization, pliability and scar height); the total score ranges from 0 to 11, with 0 representing normal skin.To assess 3 variables of scar characteristics: Vascularity, pliability and height. Scoring; vascularity ranged from 0 to 3 (1 Pink, 2 Red, 3 Purple), pliability ranged from 0 to 5 (1 Supple, 2 Yielding, 3 Firm, 4 Ropes, 5 Contracture) and height ranged from 0 to 3 (1 Less than 2 mm, 2 From 2 to 5 mm, 3 More than 5 mm). The larger the total score, the worse the HTS. The investigators choose an algebraic value for any of these characteristics based on a comparison with normal skin (zero score)
- A Schiotz tonometer scale :
This scale will be used as an objective scale to asses the hypertrophic scar pliability and elasticity.
The tissue tonometer provides a repeatable and objective index of burn scar pliability. it is a simple, clinically useful technique for monitoring an individual's scar.
To assess scar pliability and elasticity improvement by an objective manner It is held vertically at a measured point of the scar, so the plunger moved downwards by gravity and indent the scar tissue. The instrument gives a reading on a horizontal scale numbered arbitrarily from 0 to 20, but the device does not measure scar pressure directly, a conversion table, supplied with the Schiotz tonometer pressure directly, a conversion table, supplied with the Schiotz tonometer, is used to translate the instrument readings into measurements by mmHg .
Treatment procedure :
- Pulsed High Intensity Laser application procedure:
- Should wear laser-protective glasses or goggles.
- Inappropriate use of the goggles is more dangerous than their non-use, as they may provide a false sense of security.
- Laser equipment should be placed in a controlled area with minimal access to avoid inadvertent exposure.
- Avoid laser reflection from mirrored surfaces.
- Avoid exposure of eyes, unclosed fontanels of children.
- Applied at at fluence of 40 J/cm2 , pulse duration of 0.3 m/s , spot size of 5 mm in a focused mode for 3 passes.
- Extracorporeal shockwave application procedure:
- Patients will receive sessions of ESWT twice a week for 6 weeks.
- ESWT will be administered on an outpatient basis; the selected treatment area is usually the most uncomfortable for the patient. Patient placed into comfortable position that allowed the vision of the treated area.
- Each treatment region covered with 2500 to 3000 impulses with average session time 10-15 min. conservative treatment for both groups: (Stretching exercises and Deep friction massage ) 2 sessions per week for 6 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A (30 patients receive pulsed high intensity laser plus taditional PT treatment for postburn hypertrophic scar. Groyp B (30 patients recaive extracorporeal shockwave therapy plus traditional PT treatment for post burn hypertrophic scar.
| Arm | Type | Receives |
|---|---|---|
| study group receives pulsed high intensity laser and coservative treatment | Active comparator | Device: pulsed high intensity laser therapy |
| study group receives extracorporeal shockwave therapy and coservative treatment | Active comparator | Device: Extracorporeal shockwave therapy |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patients age will range from 20 to 45 years.
- All patients will be free from any other pathological conditions or histories except hypertrophic scar.
- patients will be selected from both gender.
- All patients will have hypertrophic scars post burn injuries.
Key exclusion criteria (6 listed)
- The patients who have open wound at or near treatment site.
- The patients who have cardiac pacemakers or other implanted electronic devices.
- The patients who have any significant health problem such as diabetes, circulatory
- disorders or history of skin malignancy in the treated area.
- uncooperative patients.
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 |
|---|---|---|
| pulsed high intensity laser therapyThe high-intensity laser therapy (HILT), which involves laser radiation with high-intensity, is a kind of novel and powerful . The HILT possesses its own photomechanical, photothermal, and the photo-chemical properties. | Device | study group receives pulsed high intensity laser and coservative treatment |
| Extracorporeal shockwave therapyExtracorporeal shockwave therapy is an acoustic wave that mechanically disrupts tissue by cavitation.Shock waves develop microscopic injuries in scar tissue and break down collagen fibers which lead to scar remodelin .The patient is positioned in a comfortable position. The scar site is prepared with contact gel to conduct the shock waves, 30-50 shocks/cm2 , with an energy flux density of 0.25mJ/mm2 and a frequency of 6Hz. Each treatment region is covered with 2500 to 3000 impulses with an average session time of 10-15min . | Device | study group receives extracorporeal shockwave therapy and coservative treatment |
Primary outcome
Modified Vancouver burn Scar assessment scale
Time frame: change of the total score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)
Modified Vancouver scar scale , an observer-dependent scale of the macroscopic appearance of scarring, is used to measure changes in the scar over the period of treatment,The Modified Vancouver Scar Scale score is probably the most widely known scar scale that consists of three components (vascularization, pliability and scar height); the total score ranges from 0 to 11, with 0 representing normal skin ,Scoring; vascularity ranged from 0 to 3 (1 Pink, 2 Red, 3 Purple), pliability ranged from 0 to 5 (1 Supple, 2 Yielding, 3 Firm, 4 Ropes, 5 Contracture) and height ranged from 0 to 3 (1 Less than 2 mm, 2 From 2 to 5 mm, 3 More than 5 mm). The larger the total score, the worse the HTS. The investigators choose an algebraic value for any of these characteristics based on a comparison with normal skin (zero score).
1 secondary outcome
Aschiotz tonometer device
Time frame: change of the hypertrohic scar pressure score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Results publication: PubMed 35115845Ruchiatan K, Suhada KU, Hindritiani R, Puspitosari D, Septrina R. Combination of 1064 nm Long-Pulsed and Q-Switched Nd:YAG Laser for Facial Hypertrophic Scar and Hyperpigmentation Following Burn Injury. Int Med Case Rep J. 2022 Jan 25;15:23-27. doi: 10.2147/IMCRJ.S348091. eCollection 2022.
- Results publication: PubMed 32917473Lee SY, Joo SY, Cho YS, Hur GY, Seo CH. Effect of extracorporeal shock wave therapy for burn scar regeneration: A prospective, randomized, double-blinded study. Burns. 2021 Jun;47(4):821-827. doi: 10.1016/j.burns.2020.08.009. Epub 2020 Aug 29.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Haidy Nady Ashem, professor contact
Haidy Nady Ashem, professor study director
faculty of physical therapy
Questions about this trial
What is this clinical trial studying?
A study testing pulsed high intensity laser therapy and Extracorporeal shockwave therapy in people with Hypertrophic Scar, run by Cairo University.
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 6 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: opening soon, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Fayed Ali, Bachelor's (01011172739, fayedamira82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Vancouver burn Scar assessment scale (time frame: change of the total score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)). 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 NCT06803472, which also lists 2 linked publications.
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 31 Jan 2025.