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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04198454

Enrollment

Registered

2019-12-13

Start date

2020-02-17

Completion date

2028-06-01

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Healing

Brief 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.

Interventions

OTHERCompression bandages

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

OTHERStandard wound dressings

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

DEVICEFractional ablative carbon dioxide laser

Participant will have laser applied to their wound bed.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Sequential, multiple assignment, randomized trials (SMARTs)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMurad Alam, MD

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026