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Compression and CO2 Laser for Leg Wounds

NCT04198454 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-01-31

No results posted yet for this study

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

Interventions

OTHER

Compression bandages

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

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Murad Alam, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-17
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198454 on ClinicalTrials.gov