Compression and CO2 Laser for Leg Wounds | NCT04198454

Studies
Compression and CO2 Laser for Leg Wounds

NCT04198454

Sponsor

Northwestern University

Status

Enrolling by invitation

Last Update Posted

Jul 1, 2026Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Wound Healing

Interventions

Compression bandages
Standard wound dressings
Fractional ablative carbon dioxide laser

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2020Actual

Primary Completion Date

Jun 2028Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

Dec 12, 2019

First Submission Date that Met QC Criteria

Dec 12, 2019

First Posted Date

Dec 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2026

Last Update Posted Date

Jul 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Compression bandages	Other	Class I (20-30 mmHg) compression bandages or stocking	Compression bandages Compression bandages with FACL

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

Eligibility Module

Eligibility Criteria

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:

>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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Murad Alam, MD	Northwestern University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Department of Dermatology		Chicago	Illinois	60611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001458	Bandages
D004864	Equipment and Supplies