NCT04198454

Compression and CO2 Laser for Leg Wounds

Randomized, Investigator-blinded Study of Compression in Wound Healing With and Without Fractional Ablative CO2 Laser After Excisions on the Lower Extremity (CHIME+)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Wound Healing

Interventions

Type	Name	Description
OTHER	Compression bandages	Class I (20-30 mmHg) compression bandages or stocking
OTHER	Standard wound dressings	Wound dressings alone consisting of gauze and skin tape to cover the wound
DEVICE	Fractional ablative carbon dioxide laser	Participant will have laser applied to their wound bed.

Timeline

• Start date: 2020-02-17
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2019-12-13
• Last updated: 2025-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study