Compression and CO2 Laser for Leg Wounds
Enrolling by invitation · Not applicable
Conditions studied: Wound Healing
In brief
The purpose of this study is to determine the efficacy and safety of compression bandaging with fractional ablative carbon dioxide laser (FACL) compared to compression and standard dressings alone for healing of post-operative wounds of the leg. This is a randomized, SMART design, clinical trial. Approximately 80 participants will be randomized to initially receive compression bandages or standard wound dressings after surgery on the lower leg. After 4 weeks, the group assigned to compression bandages will be further randomized to either continue with the compression bandages only or continue with the compression bandages and also receive (FACL). The study is designed as an 6-month study. This study was a pilot study designed to determine feasibility of these procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
Key facts
- Study ID
- NCT04198454
- Run by
- Northwestern University
- People needed
- 80
- Starts
- 2020-02-17
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Current smoker
- Uncontrolled diabetes mellitus
- Uncontrolled hypothyroidism
- Severe renal impairment or hypoalbuminemia
- Chronic lymphedema
- Severe venous insufficiency (large varicose veins, atrophie blanche)
- Arterial insufficiency (ABI < 0.8)
- Rubber or rubber accelerator allergy
- Prior radiation to the surgical site
- History or evidence of a clinically significant medical or psychiatric disorder, condition or disease that in the opinion of the treating physician would pose a risk or interfere with evaluation or completion of the study
- Subject un willing to sign an IRB approved consent form
- Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
Where it is running
- Northwestern University Department of Dermatology — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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