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+)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Wound Healing
• Intervention / Treatment: Other: Compression bandages; Other: Standard wound dressings; Device: Fractional ablative carbon dioxide laser

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:Patients will be identified through the clinic where their skin is to be treated by excisional surgery on the lower leg. Those considered for enrollment must also meet the following criteria:

1. >18 years of age
2. Wound size of at least 1 cm in width
3. Cutaneous excision of the lower leg
4. Surgeon elected repair of healing by secondary intention
5. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

1. Current smoker
2. Uncontrolled diabetes mellitus
3. Uncontrolled hypothyroidism
4. Severe renal impairment or hypoalbuminemia
5. Chronic lymphedema
6. Severe venous insufficiency (large varicose veins, atrophie blanche)
7. Arterial insufficiency (ABI < 0.8)
8. Rubber or rubber accelerator allergy
9. Prior radiation to the surgical site
10. 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
11. Subject un willing to sign an IRB approved consent form
12. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Compression bandages; 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.	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.	Other: Standard wound dressings; Wound dressings alone consisting of gauze and skin tape to cover the wound
Experimental: Compression bandages with FACL; Class I compression (20-30 mmHg) bandage or stocking with FACL.	Other: Compression bandages; Class I (20-30 mmHg) compression bandages or stocking; Device: Fractional ablative carbon dioxide laser; Participant will have laser applied to their wound bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change wound size as determined by measurements	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Murad Alam, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: STU00211239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No