Burn ScarNCT03697447
Endermotherapy With Burn Hypertrophic Scars
A study testing Endermotherapy in people with Burn Scar, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Mechanical massage or endermotherapyTM is applied to scar tissue with the intended therapeutic value being the promotion of structural or physiological changes. These proposed changes are meant to induce more pliability, so that skin possesses the strength and elasticity required for normal mobility. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Burn Scar
- What is being tested?
- Endermotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 13 Feb 2017to 5 Feb 2020
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- females and males, of any race, 14 years or older,
- a thermal injury,
- at least 3 months post-burn so that the scars will be durable enough to tolerate the proposed forces,
- at least 2 scar sites >2.034 mm thick and within 0.5 mm of each other, and
- signed the informed patient consent form
Who cannot join
- subjects who have keloids,
- with a diagnosis of psychiatric illness clearly documented in their medical file,
- mechanism of injury is an electrical, chemical, or cold injury,
- a dermatological conditions in the region of the evaluation site, that may interfere with the study results,
- a suspected or known allergy to ultrasound gel,
- unable to understand French or English, or
- subjects who refuse to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Within-patient, Singleblind Study to Evaluate the Efficacy of 12-weeks of Endermotherapy With Adult Burn Survivors
Mechanical massage or endermotherapyTM is applied to scar tissue with the intended therapeutic value being the promotion of structural or physiological changes. These proposed changes are meant to induce more pliability, so that skin possesses the strength and elasticity required for normal mobility. The advantage of mechanical massage compared to manual massage is that it provides a standard dosage using rollers and suction valves to mobilize the tissue. However, research documenting and supporting this effect is lacking. The objective of this proposal is to document the effect of 12 weeks of endermotherapy treatment on hypertrophic scar characteristics, including erythema, pigmentation, pliability, and thickness in adult burn survivors and their subjective evaluation of itch, pain and overall scar outcome through a prospective, randomized, controlled, within-patient, single-blinded study.
Read the detailed description
Patients will receive 12 weeks of endermotherapy , 3 times a week.
- Conditions
- Burn Scar
- Being tested
- Endermotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndermotherapyProcedure or surgery
Endermotherapy massage (mechanic massage) of burn scar
| Study group | Role | What they receive |
|---|---|---|
| Endermotherapy treated scar | Experimental | Endermotherapy massage treatment Receives: Procedure: Endermotherapy |
| Control scar | No intervention | No intervention, standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Thickness Changes
Ultrasound skin measures, mm
Measured: baseline, 12, 24 and 36 weeks
Secondary outcomes (4)
Cutometer Skin Elasticity Changes
skin elasticity measures (r0- cutometer), mm
Measured: baseline, 12, 24 and 36 weeks
Mexameter Skin Erythema Changes
Erythema index measure by Mexameter, scale values of 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Measured: baseline, 12, 24 and 36 weeks
Itch Visual Analog Subjective Changes
Itch, Visual analog scale (score 0-none to 10-worse)
Measured: baseline, 12, 24 and 36 weeks
Pain Visual Analog Subjective Changes: VAS
Pain, Visual analog scale (score 0-none to 10-worse)
Measured: baseline, 12, 24 and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start13 Feb 2017
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernadette Nedelec, PhD, Principal investigator, CRCHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697447
- Sponsor's protocol ID
- 15.374
- Status last verified
- Aug 2024
- First submitted
- 22 Mar 2018
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Within-patient, Singleblind Study to Evaluate the Efficacy of 12-weeks of Endermotherapy With Adult Burn Survivors
- ClinicalTrials.gov ID
- NCT03697447
- Acronym / sponsor ID
- 15.374
- Conditions
- Burn Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 5 Oct 2018 (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.
Mechanical massage or endermotherapyTM is applied to scar tissue with the intended therapeutic value being the promotion of structural or physiological changes. These proposed changes are meant to induce more pliability, so that skin possesses the strength and elasticity required for normal mobility. The advantage of mechanical massage compared to manual massage is that it provides a standard dosage using rollers and suction valves to mobilize the tissue. However, research documenting and supporting this effect is lacking. The objective of this proposal is to document the effect of 12 weeks of endermotherapy treatment on hypertrophic scar characteristics, including erythema, pigmentation, pliability, and thickness in adult burn survivors and their subjective evaluation of itch, pain and overall scar outcome through a prospective, randomized, controlled, within-patient, single-blinded study.
Detailed description
Patients will receive 12 weeks of endermotherapy , 3 times a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endermotherapy treated scar | Experimental | Procedure: EndermotherapyEndermotherapy massage treatment |
| Control scar | No intervention | –No intervention, standard of care |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- females and males, of any race, 14 years or older,
- a thermal injury,
- at least 3 months post-burn so that the scars will be durable enough to tolerate the proposed forces,
- at least 2 scar sites >2.034 mm thick and within 0.5 mm of each other, and
- signed the informed patient consent form
Key exclusion criteria (7 listed)
- subjects who have keloids,
- with a diagnosis of psychiatric illness clearly documented in their medical file,
- mechanism of injury is an electrical, chemical, or cold injury,
- a dermatological conditions in the region of the evaluation site, that may interfere with the study results,
- a suspected or known allergy to ultrasound gel,
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 |
|---|---|---|
| EndermotherapyEndermotherapy massage (mechanic massage) of burn scar | Procedure or surgery | Endermotherapy treated scar |
Primary outcome
Skin Thickness Changes
Time frame: baseline, 12, 24 and 36 weeks
Ultrasound skin measures, mm
4 secondary outcomes
Cutometer Skin Elasticity Changes
Time frame: baseline, 12, 24 and 36 weeks
Mexameter Skin Erythema Changes
Time frame: baseline, 12, 24 and 36 weeks
Itch Visual Analog Subjective Changes
Time frame: baseline, 12, 24 and 36 weeks
Pain Visual Analog Subjective Changes: VAS
Time frame: baseline, 12, 24 and 36 weeks
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 21 Aug 2024.
- 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.
Bernadette Nedelec, PhD principal investigator
CRCHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endermotherapy in people with Burn Scar, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 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 21 Aug 2024. 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 Canada. 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?
Skin Thickness Changes (time frame: baseline, 12, 24 and 36 weeks). 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 21 Aug 2024.