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Laser Therapy for Scarring and Fibrosis in Amputees (LASER Trial)
N/A
Recruiting
Led By Jeffrey T Heckman, DO
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post treatment laser visit (week 6), and 3 and 6 month follow up visits
Awards & highlights
LASER Trial Summary
This trial will study if a laser therapy can help Veterans with amputations reduce pain & discomfort from skin problems so they can wear their prosthetic limb.
Who is the study for?
This trial is for Veterans aged 21-70 with lower limb amputations who regularly use prostheses but experience discomfort due to scarring. Participants must understand the study, attend sessions, and have skin issues treatable by laser therapy. Those without prosthesis-related skin problems or with open wounds/infections are excluded.Check my eligibility
What is being tested?
The LASER Pilot Project tests whether fractional CO2 laser ablative resurfacing can help Veterans with amputations improve their comfort and quality of life when using lower limb prostheses by managing scars and other skin issues.See study design
What are the potential side effects?
Potential side effects from fractional CO2 laser treatment may include temporary redness, swelling, itching at the treatment site, changes in skin pigmentation, and a slight risk of burns or scarring.
LASER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and post treatment laser visit (week 6), and 3 and 6 month follow up visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post treatment laser visit (week 6), and 3 and 6 month follow up visits
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 2 minute walk test
Change in Dermal Torque Meter
Change in Dermatology Life Quality Index
+6 moreLASER Trial Design
1Treatment groups
Experimental Treatment
Group I: Observational Single ArmExperimental Treatment1 Intervention
All subjects will have scars, quality of life, function assessed pre and post laser treatment
Find a Location
Who is running the clinical trial?
Miami Dermatology and Laser InstituteOTHER
2 Previous Clinical Trials
49 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,264 Total Patients Enrolled
Bruce W. Carter VA Medical CenterUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not eligible for laser therapy.I use a lower limb prosthetic without issues from scarring or skin problems.My amputated limb has an open wound or infection.I am between 21 and 70 years old.I can attend all required assessment sessions before and after the procedure.I can attend all skin and laser treatment appointments.I understand the study details and agree to follow its rules.I have had an amputation above or below the knee.I have skin issues from my leg prosthesis that might improve with laser therapy.I have an open wound, infection, or unstable skin from a recent injury.
Research Study Groups:
This trial has the following groups:- Group 1: Observational Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings remaining for participants in this research program?
"The current status of this medical trial, as reported on clinicaltrials.gov, is not accepting participants. Initially posted on September 1st 2023 and last modified on July 25th 2023, this study has since ceased recruitment; however there are 396 other trials actively recruiting individuals at the moment."
Answered by AI
Who is eligible to take part in this research?
"To participate in this medical research, applicants must have undergone amputation and be between 21-70 years old. Only a maximum of 20 patients are being sought after for the trial."
Answered by AI
Is the age limit for participants in this experiment greater than thirty-five years?
"According to the study's requirements, participants should be within 21 and 70 years old. Additionally, there are 68 trials for minors and 366 trials available specifically for seniors."
Answered by AI
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