Compression and CO2 Laser for Leg Wounds

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT04198454
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 17, 2020
Status verified
Jan 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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: 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.

Primary Outcome Measure

Mean change wound size as determined by measurements [ Time Frame: Baseline to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University Department of DermatologyChicagoIllinois60611-

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Northwestern University Department of Dermatology· Chicago, IL

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