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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of compression bandages combined with a fractional ablative carbon dioxide laser treatment in healing leg wounds post-surgery, compared to using only bandages or regular dressings. The researchers aim to determine if the laser treatment accelerates and enhances the safety of wound healing. Individuals who have recently undergone lower leg surgery and require natural wound healing may qualify for this study. Participants should reside in the Chicago area and meet specific health criteria. As an unphased trial, this study provides a unique opportunity to contribute to innovative wound healing research.

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 prior data suggests that this protocol is safe for leg wound healing?

Research has shown that fractional ablative carbon dioxide laser (FACL) treatments are generally safe for aiding wound healing. Studies have found that this laser treatment can accelerate healing and may reduce pain. It has been successfully used in patients with diabetes, demonstrating its safety and effectiveness in various situations.

Additionally, compression bandages, which gently press on the wound area, are commonly recommended for treating lower leg wounds and are well-tolerated by patients.

These findings suggest that combining FACL with compression bandages is likely safe for participants, with no major safety concerns reported in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of CO2 laser combined with compression bandages for leg wound healing because it integrates two powerful approaches. Unlike standard wound dressings or compression bandages alone, this combination leverages the CO2 laser's ability to enhance tissue repair and stimulate healing at a cellular level. This method not only aims to speed up the healing process but also potentially improves the quality of recovery, offering a promising advancement over traditional treatments.

What evidence suggests that this trial's treatments could be effective for leg wound healing?

Research has shown that using a special laser treatment called fractional ablative carbon dioxide laser (FACL) with compression bandages can accelerate the healing of leg wounds. In this trial, one group of participants will receive compression bandages with FACL, another group will receive compression bandages alone, and a third group will receive standard wound dressings. Studies have found that FACL not only improves the appearance of surgical scars but also speeds up and enhances the healing process. It can also help reduce pain and lower overall treatment costs. While compression bandages are commonly used to aid wound healing, combining them with FACL might lead to even better results. Early evidence suggests this combination could be very beneficial for people recovering from leg surgeries. ^{3 5 6 7 8}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25946007/

Ablative Fractional Carbon Dioxide Laser in the Treatment ... Fractional carbon dioxide laser treatment appeared to accelerate healing in each of these posttraumatic wounds. It may be a helpful adjunct in nonhealing ...

2. liebertpub.com liebertpub.com/doi/10.1089/wound.2024.0213

Treatment of Surgical Scars with Fractional Carbon Dioxide ... This study demonstrates that CO 2 FL achieves more significant long-term results in surgical scars, including improved scar appearance, safety, and patient ...

3. semanticscholar.org semanticscholar.org/paper/Ablative-Fractional-Carbon-Dioxide-Laser-in-the-of-Phillips-Morton/920be5e18efd081925a97454bb6a6b6e9da1d1ee

Ablative Fractional Carbon Dioxide Laser in the Treatment ... Fractional carbon dioxide laser treatment appeared to accelerate healing in each of these posttraumatic wounds, suggesting that this treatment modality may ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03644849

Evaluating the Safety and Efficacy of Fractionated Carbon ... This study will evaluate the efficacy and safety of laser therapy on postoperative lower extremity wound healing over 12 weeks.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0039606023009133

Impact of ultra-pulse carbon dioxide laser on the treatment ... This study demonstrates that ultra-pulse CO 2 laser treatment significantly improves wound healing, reduces pain, and lowers treatment costs

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/lsm.23490

Efficacy and safety of CO 2 laser in the treatment of chronic ... The present study aimed to investigate the efficacy and safety of fully ablative CO2 laser debridement compared to routine surgical debridement ...

7. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/209602

Successful Treatment of Atrophic Postoperative and ... The AFR treatments represent a safe, effective treatment modality for improving atrophic scarring due to surgery or trauma.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11163927/

Use of carbon dioxide fractional laser in the management ... This case report provides guidance for the performance of CO 2 FL, a fast, easy, accurate treatment in patients with diabetes.