Compression and CO2 Laser for Leg Wounds

NCT04198454 | Enrolling By Invitation FDA Device

• 1 other identifier: STU00211239
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

• Mean change wound size as determined by measurements

  Baseline to 6 months

Study Arms (3)

Compression bandages

ACTIVE COMPARATOR

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

Standard wound dressings

OTHER

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

Other: Standard wound dressings

Compression bandages with FACL

EXPERIMENTAL

Class I compression (20-30 mmHg) bandage or stocking with FACL.

Other: Compression bandages; Device: Fractional ablative carbon dioxide laser

Interventions

Compression bandages OTHER

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

Compression bandages; Compression bandages with FACL

Standard wound dressings OTHER

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

Standard wound dressings

Fractional ablative carbon dioxide laser DEVICE

Participant will have laser applied to their wound bed.

Compression bandages with FACL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Compression Bandages

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Model Details: Sequential, multiple assignment, randomized trials (SMARTs)

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 13, 2019
• Study Start: February 17, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)