Wound HealingNCT04198454
Compression and CO2 Laser for Leg Wounds
A study testing Compression bandages, Standard wound dressings and Fractional ablative carbon dioxide laser in people with Wound Healing, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- Compression bandages, Standard wound dressings and Fractional ablative carbon dioxide laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Current smoker
- Uncontrolled diabetes mellitus
- Uncontrolled hypothyroidism
- Severe renal impairment or hypoalbuminemia
- Chronic lymphedema
- Severe venous insufficiency (large varicose veins, atrophie blanche)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
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+)
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
- Being tested
- Compression bandages, Standard wound dressings, Fractional ablative carbon dioxide laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression bandagesOther
Class I (20-30 mmHg) compression bandages or stocking
Standard wound dressingsOther
Wound dressings alone consisting of gauze and skin tape to cover the wound
Fractional ablative carbon dioxide laserDevice
Participant will have laser applied to their wound bed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Compression bandages |
| Standard wound dressings | Other | Wound dressings alone consisting of gauze and skin tape to cover the wound. Receives: Other: Standard wound dressings |
| Compression bandages with FACL | Experimental | Class I compression (20-30 mmHg) bandage or stocking with FACL. Receives: Other: Compression bandages; Device: Fractional ablative carbon dioxide laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change wound size as determined by measurements
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start17 Feb 2020
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential, multiple assignment, randomized trials (SMARTs)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198454
- Sponsor's protocol ID
- STU00211239
- Status last verified
- May 2026
- First submitted
- 12 Dec 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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+)
- ClinicalTrials.gov ID
- NCT04198454
- Acronym / sponsor ID
- STU00211239
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Sequential, multiple assignment, randomized trials (SMARTs)
| Arm | Type | Receives |
|---|---|---|
| Compression bandages | Active comparator | Other: Compression bandagesClass I (20-30 mmHg) compression bandages or stocking. This is considered a standard measure in the recovery of lower extremity wounds and often recommended. |
| Standard wound dressings | Other | Other: Standard wound dressingsWound dressings alone consisting of gauze and skin tape to cover the wound. |
| Compression bandages with FACL | Experimental | Other: Compression bandages, Device: Fractional ablative carbon dioxide laserClass I compression (20-30 mmHg) bandage or stocking with FACL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Current smoker
- Uncontrolled diabetes mellitus
- Uncontrolled hypothyroidism
- Severe renal impairment or hypoalbuminemia
- Chronic lymphedema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression bandagesClass I (20-30 mmHg) compression bandages or stocking | Other | Compression bandages, Compression bandages with FACL |
| Standard wound dressingsWound dressings alone consisting of gauze and skin tape to cover the wound | Other | Standard wound dressings |
| Fractional ablative carbon dioxide laserParticipant will have laser applied to their wound bed. | Device | Compression bandages with FACL |
Primary outcome
Mean change wound size as determined by measurements
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression bandages, Standard wound dressings and Fractional ablative carbon dioxide laser in people with Wound Healing, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change wound size as determined by measurements (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.