Hypertrophic ScarNCT06940999
An Innovative Image-Based Method for Extensibility Assessment
A study testing Traditional physical therapy in people with Hypertrophic Scar, run by Cairo University at 1 site in Egypt.
Trial summary
This study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- Traditional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2025to 10 Oct 2026
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of clinically diagnosed scar contracture following thermal burns.
- Presence of scars (≥6 months post-burn) to ensure stability for accurate assessment.
- Scars located on functionally mobile areas (e.g., limbs) where extensibility impacts daily activities.
- Willingness to undergo a standardized physical therapy intervention.
- Ability to provide informed consent and comply with all study procedures.
Who cannot join
- Active infection, unhealed wounds, or unstable scars at the assessment site.
- Diagnosed systemic diseases affecting collagen synthesis or wound healing (e.g., scleroderma, uncontrolled diabetes).
- History of experimental or non-standard scar treatment within the last 3 months.
- Severe cognitive impairments or communication barriers that interfere with understanding or participation.
- Pregnant or lactating women, due to hormonal influences on tissue healing and collagen metabolism.
- Concurrent participation in other physical therapy or rehabilitation studies targeting scar management.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Revolutionizing Scar Evaluation: An Innovative Image-Based Method for Extensibility Assessment
This study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach.
Read the detailed description
- Quasi-experimental, single-group pre-post intervention: Participants will receive a standardized physical therapy protocol targeting scar contracture. After intervention, scar extensibility will be measured using traditional tools (Vancouver Scar Scale, tonometer) and a newly developed image-based method.
- Methodological validation approach: The image-based method will be tested for:
- Reliability (test-retest, inter-rater)
- Validity (concurrent validity against established tools and construct validity)
- Conditions
- Hypertrophic Scar
- Being tested
- Traditional physical therapy
- Keywords
- Image-based assessment, Scar extensibility assessment.
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional physical therapyOther
Application of laser three times per week in addition to applying deep friction massage, stretching exercises along with the uses of pressure garment.
| Study group | Role | What they receive |
|---|---|---|
| Traditional physical therapy group | Experimental | This study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach.
Participants will receive a standardized physical therapy protocol targeting scar contracture. After intervention, scar extensibility will be measured using traditional tools (Vancouver Scar Scale, tonometer) and a newly developed image-based method. The image-based method will be tested for:
* Reliability (test-retest, inter-rater)
* Validity (concurrent validity against established tools and construct validity) Receives: Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Scar Scale (VSS)
to evaluate vascularity, pigmentation, pliability, and scar height.
Measured: Baseline and three months after the intervention
Firmness and pliability at the scar site
Tonometry will be used to assess tissue firmness and pliability at the scar site.
Measured: Baseline and three months after the intervention
Proposed Image-Based Method
the scar images before and after the intervention will go through three steps:
- Image Acquisition: High-resolution digital images of scars will be captured using a standardized protocol (fixed camera settings, lighting, distance).
- Image Preprocessing: Images will be converted to grayscale, and regions of interest (ROI) manually or automatically defined.
- Image Analysis: The standard deviation (STD) of pixel intensities within the ROI will be calculated as an indicator of tissue extensibility and collagen fiber cross-linking patterns will be detected and quantified using advanced image processing algorithms.
Measured: Baseline and three months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start15 Aug 2025
- Primary completion4 Aug 2026
- Study completion10 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed-method design combining quasi-experimental and instrument validation approaches
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
- Investigators
- Shaimaa MA Elsayeh, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940999
- Sponsor's protocol ID
- P.T.REC/012/005678
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revolutionizing Scar Evaluation: An Innovative Image-Based Method for Extensibility Assessment
- ClinicalTrials.gov ID
- NCT06940999
- Acronym / sponsor ID
- P.T.REC/012/005678
- Conditions
- Hypertrophic Scar
- Keywords
- Image-based assessment, Scar extensibility assessment.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 10 Oct 2026 (actual)
- First posted
- 23 Apr 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.
This study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach.
Detailed description
- Quasi-experimental, single-group pre-post intervention: Participants will receive a standardized physical therapy protocol targeting scar contracture. After intervention, scar extensibility will be measured using traditional tools (Vancouver Scar Scale, tonometer) and a newly developed image-based method.
- Methodological validation approach: The image-based method will be tested for:
- Reliability (test-retest, inter-rater)
- Validity (concurrent validity against established tools and construct validity)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed-method design combining quasi-experimental and instrument validation approaches
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy group | Experimental | Other: Traditional physical therapyThis study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach. Participants will receive a standardized physical therapy protocol targeting scar contracture. After intervention, scar extensibility will be measured using traditional tools (Vancouver Scar Scale, tonometer) and a newly developed image-based method. The image-based method will be tested for: * Reliability (test-retest, inter-rater) * Validity (concurrent validity against established tools and construct validity) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- History of clinically diagnosed scar contracture following thermal burns.
- Presence of scars (≥6 months post-burn) to ensure stability for accurate assessment.
- Scars located on functionally mobile areas (e.g., limbs) where extensibility impacts daily activities.
- Willingness to undergo a standardized physical therapy intervention.
- Ability to provide informed consent and comply with all study procedures.
Key exclusion criteria (6 listed)
- Active infection, unhealed wounds, or unstable scars at the assessment site.
- Diagnosed systemic diseases affecting collagen synthesis or wound healing (e.g., scleroderma, uncontrolled diabetes).
- History of experimental or non-standard scar treatment within the last 3 months.
- Severe cognitive impairments or communication barriers that interfere with understanding or participation.
- Pregnant or lactating women, due to hormonal influences on tissue healing and collagen metabolism.
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 |
|---|---|---|
| Traditional physical therapyApplication of laser three times per week in addition to applying deep friction massage, stretching exercises along with the uses of pressure garment. | Other | Traditional physical therapy group |
Primary outcome
Vancouver Scar Scale (VSS)
Time frame: Baseline and three months after the intervention
to evaluate vascularity, pigmentation, pliability, and scar height.
Firmness and pliability at the scar site
Time frame: Baseline and three months after the intervention
Tonometry will be used to assess tissue firmness and pliability at the scar site.
Proposed Image-Based Method
Time frame: Baseline and three months after the intervention
the scar images before and after the intervention will go through three steps: * Image Acquisition: High-resolution digital images of scars will be captured using a standardized protocol (fixed camera settings, lighting, distance). * Image Preprocessing: Images will be converted to grayscale, and regions of interest (ROI) manually or automatically defined. * Image Analysis: The standard deviation (STD) of pixel intensities within the ROI will be calculated as an indicator of tissue extensibility and collagen fiber cross-linking patterns will be detected and quantified using advanced image processing algorithms.
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 15 Oct 2026.
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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.
Shaimaa MA Elsayeh, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional physical therapy in people with Hypertrophic Scar, run by Cairo University at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 15 Oct 2026. 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 Egypt. 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?
Vancouver Scar Scale (VSS) (time frame: Baseline and three months after the intervention). The study lists 3 primary outcomes in all. 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 15 Oct 2026.