Compression and CO2 Laser for Leg Wounds

Wound Healing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04198454
• Other study ID #: STU00211239
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

Intervention

Other:
• Compression bandages
Class I (20-30 mmHg) compression bandages or stocking
• 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.

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change wound size as determined by measurements		Baseline to 6 months