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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Amira Fayed Ali, Bachelor's contact

01011172739

fayedamira82@gmail.com

Haidy Nady Ashem, professor contact

haidyjoj.hn@gmail.com

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
  1. 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.
  2. Design of the study :

In this study, the patients will be randomly divided into two equal groups in number (30 patients each).

  1. 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.
  2. 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 :

  1. 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)
  2. 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 :

  1. 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.
  1. 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
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 groups in NCT06803472
Study groupRoleWhat they receive
study group receives pulsed high intensity laser and coservative treatmentActive comparatorNot described
Receives: Device: pulsed high intensity laser therapy
study group receives extracorporeal shockwave therapy and coservative treatmentActive comparatorNot described
Receives: Device: Extracorporeal shockwave therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted31 Jan 2025
  2. Study start26 Jan 2025 (estimated)
  3. Primary completion10 Feb 2025 (estimated)
  4. Study completion25 Mar 2025 (estimated)

Resources

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)
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 35115845
  • Lee 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

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.

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