CO2 Laser + Compression for Leg Wound Healing

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Smoking, Diabetes, Hypothyroidism, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What data supports the effectiveness of the treatment CO2 Laser + Compression for Leg Wound Healing?

Research suggests that advanced wound dressings, like those used in combination with compression, may improve healing rates for leg ulcers compared to compression alone. Additionally, compression therapy is a common and effective treatment for venous leg ulcers, which supports its use in wound healing. ^{1 2 3 4 5}

Is the CO2 Laser + Compression treatment safe for leg wound healing?

Compression bandages are generally considered safe for treating leg ulcers, as studies have evaluated their safety and effectiveness in various conditions. However, the quality of research on advanced wound dressings, which may include CO2 laser treatments, is limited, and more studies are needed to confirm their safety. ^{1 3 6 7 8}

How does the CO2 Laser + Compression treatment for leg wound healing differ from other treatments?

The CO2 Laser + Compression treatment is unique because it combines laser therapy, which can stimulate tissue repair and reduce inflammation, with compression bandages that improve blood flow and support faster healing. This dual approach may offer enhanced healing benefits compared to using compression or standard wound dressings alone. ^{1 3 7 9 10}

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults over 18 in the Chicago area with leg wounds at least 1 cm wide from lower leg surgery, who agree to sign a consent form. It's not for those with rubber allergies, uncontrolled diabetes or hypothyroidism, severe kidney issues, poor blood flow in legs (ABI < 0.8), significant health conditions that could affect the study, smokers, prior radiation at the surgical site, or severe vein problems.

Inclusion Criteria

I am scheduled for skin surgery on my lower leg at the clinic.

Exclusion Criteria

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

I have severe vein problems with large varicose veins.

My diabetes is not well-managed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive either compression bandages or standard wound dressings after surgery on the lower leg

4 weeks

Secondary Treatment

Participants initially assigned to compression bandages are further randomized to continue with compression bandages only or with FACL

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Compression Bandages
• Fractional Ablative Carbon Dioxide Laser
• Standard Wound Dressings

Trial Overview The study tests if compression bandages and fractional ablative carbon dioxide laser (FACL) are better than standard dressings alone for healing post-surgery leg wounds. Participants will first get either compression bandages or standard dressings; after four weeks some will also receive FACL treatment.

Participant Groups

Group I: Standard wound dressings Experimental Treatment 1 Intervention

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

Group II: Compression bandages with FACL Experimental Treatment 2 Interventions

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

Group III: Compression bandages Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

In a study involving 42 patients with venous ulcers, a new two-bandage compression system led to a significant mean reduction of 58.5% in ulcer surface area over six weeks, with 24% of wounds healing completely in an average of 25.9 days.

Patients reported improved quality of life and comfort with the new compression system compared to their previous treatment, with excellent adherence and very good local tolerance observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety and acceptability of a new two-layer bandage system for venous leg ulcers. Benigni, JP., Lazareth, I., Parpex, P., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of advanced wound dressings for patients with chronic venous leg ulcers: a systematic review. [2018]

2. England pubmed.ncbi.nlm.nih.gov

VenUS I: a randomised controlled trial of two types of bandage for treating venous leg ulcers. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Compression therapy in an obese patient. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Measuring sub-bandage pressure: comparing the use of pressure monitors and pulse oximeters. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Increasing competence in compression therapy for venous leg ulcers through training and exercise measured by a newly developed score-Results of a randomised controlled intervention study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy, safety and acceptability of a new two-layer bandage system for venous leg ulcers. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Multi-layer compression: comparison of four different four-layer bandage systems applied to the leg. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Compression therapy in mixed ulcers increases venous output and arterial perfusion. [2012]

9. England pubmed.ncbi.nlm.nih.gov

Venous leg ulcers: short-stretch bandage compression therapy. [2005]

10. England pubmed.ncbi.nlm.nih.gov

Compression strapping: the development of a novel compression technique to enhance compression therapy and healing for 'hard-to-heal' leg ulcers. [2021]