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Endermotherapy for Burn Scars

N/A
Recruiting
Led By Bernadette Nedelec, PhD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12, 24 and 36 weeks
Awards & highlights

Study Summary

This trial will test the effects of a mechanical massage device on scar tissue, with the goal of reducing stiffness and improving elasticity. The study will last 12 weeks and compare the results to a control group.

Who is the study for?
This trial is for burn survivors, aged 14 or older, with hypertrophic scars that are at least 3 months old and thick enough to withstand treatment. Participants must understand French or English and give informed consent. It's not suitable for those with keloids, certain dermatological conditions, psychiatric illnesses, injuries from electricity/chemicals/cold, or allergies to ultrasound gel.Check my eligibility
What is being tested?
The study tests endermotherapy on burn scars over a period of 12 weeks. This mechanical massage aims to make the scar tissue more pliable using rollers and suction valves. The effects on scar coloration, thickness, flexibility as well as subjective feelings of itchiness and pain will be measured.See study design
What are the potential side effects?
While specific side effects are not detailed in this summary, potential risks may include discomfort during treatment due to skin manipulation by the device's rollers and suction valves.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12, 24 and 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12, 24 and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Skin Thickness Changes
Secondary outcome measures
Cutometer Skin Elasticity Changes
Itch Visual Analog Subjective Changes
Mexameter Skin Erythema Changes
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Endermotherapy treated scarExperimental Treatment1 Intervention
Endermotherapy massage treatment
Group II: Control scarActive Control1 Intervention
No intervention, standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endermotherapy
2010
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,589 Total Patients Enrolled
2 Trials studying Burn Scars
72 Patients Enrolled for Burn Scars
Bernadette Nedelec, PhDPrincipal InvestigatorCRCHUM
2 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Endermotherapy Clinical Trial Eligibility Overview. Trial Name: NCT03697447 — N/A
Burn Scars Research Study Groups: Control scar, Endermotherapy treated scar
Burn Scars Clinical Trial 2023: Endermotherapy Highlights & Side Effects. Trial Name: NCT03697447 — N/A
Endermotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03697447 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applications being accepted for this clinical experiment currently?

"Affirmative. According to information from clinicaltrials.gov, this research is actively enrolling patients. It was initially posted on February 13th 2017 and most recently edited on November 21st 2022; the study requires 48 participants for its single site location."

Answered by AI

How many participants is the clinical trial enrolling?

"Affirmative. The clinical trial information hosted on clinicaltrials.gov reveals that this medical study, launched in February 13th 2017, is actively searching for participants. Approximately 48 patients must be enrolled from 1 distinct site."

Answered by AI
~4 spots leftby Feb 2025