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Enrolling by Invitation

NCT Number: NCT04198454

Compression and CO2 Laser for Leg Wounds

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.

Enrolling by Invitation

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • >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

Exclusion criteria

  • 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

Treatment and study plan

Compression bandages

Other

Class I (20-30 mmHg) compression bandages or stocking

Standard wound dressings

Other

Wound dressings alone consisting of gauze and skin tape to cover the wound

Fractional ablative carbon dioxide laser

Device

Participant will have laser applied to their wound bed.

Primary outcomes

  1. Mean change wound size as determined by measurements

    Time frame: Baseline to 6 months

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Dec 13, 2019
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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