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CO2 Laser + Compression for Leg Wound Healing
N/A
Waitlist Available
Led By Murad Alam, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Those considered for enrollment must also meet the following criteria: >18 years of age, Wound size of at least 1 cm in width, Cutaneous excision of the lower leg, Surgeon elected repair of healing by secondary intention, Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights
Study Summary
This trial is testing whether using compression bandages with fractional ablative carbon dioxide laser helps heal post-operative wounds better than using compression bandages or standard wound dressings alone.
Who is the study for?
This trial is for adults over 18 in the Chicago area with leg wounds at least 1 cm wide from lower leg surgery, who agree to sign a consent form. It's not for those with rubber allergies, uncontrolled diabetes or hypothyroidism, severe kidney issues, poor blood flow in legs (ABI < 0.8), significant health conditions that could affect the study, smokers, prior radiation at the surgical site, or severe vein problems.Check my eligibility
What is being tested?
The study tests if compression bandages and fractional ablative carbon dioxide laser (FACL) are better than standard dressings alone for healing post-surgery leg wounds. Participants will first get either compression bandages or standard dressings; after four weeks some will also receive FACL treatment.See study design
What are the potential side effects?
Potential side effects may include skin irritation from bandages or lasers, allergic reactions to materials used in dressings or procedures involved in the trial. Specific side effects of FACL have not been detailed but can be similar to other laser treatments like redness and swelling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change wound size as determined by measurements
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Standard wound dressingsExperimental Treatment1 Intervention
Wound dressings alone consisting of gauze and skin tape to cover the wound.
Group II: Compression bandages with FACLExperimental Treatment2 Interventions
Class I compression (20-30 mmHg) bandage or stocking with FACL.
Group III: Compression bandagesActive Control1 Intervention
Class I (20-30 mmHg) compression bandages or stocking. This is considered a standard measure in the recovery of lower extremity wounds and often recommended.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,151 Total Patients Enrolled
1 Trials studying Wound Healing
Murad Alam, MDPrincipal InvestigatorNorthwestern University
69 Previous Clinical Trials
2,500 Total Patients Enrolled
1 Trials studying Wound Healing
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe vein problems with large varicose veins.My diabetes is not well-managed.I have had radiation therapy at the site of my upcoming surgery.My thyroid condition is not under control.You are currently smoking cigarettes.I can communicate and cooperate with my doctor without issues.I am scheduled for skin surgery on my lower leg at the clinic.You are allergic to rubber or substances used to speed up the hardening of rubber.I have severe kidney problems or low blood protein levels.I have long-term swelling in my arms or legs.
Research Study Groups:
This trial has the following groups:- Group 1: Compression bandages
- Group 2: Standard wound dressings
- Group 3: Compression bandages with FACL
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.
Is the opportunity to participate in this experiment still available?
"According to the information stored on clinicaltrials.gov, recruitment for this medical study has ceased. It was initially posted in February of 2020 and had its most recent update at the end of November 2021. Nevertheless, there are still 757 other trials actively seeking patients currently."
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