Evaluating the Safety and Efficacy of Fractionated Carbon Dioxide Therapy in Postoperative Lower Extremity Wound Healing

NCT03644849 | Completed Results FDA Device

• 1 other identifier: 29076
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the efficacy and safety of laser therapy on postoperative lower extremity wound healing over 12 weeks. The investigators will include adult patients who have underwent Mohs Micrographic Surgery on their lower extremities. Patients with poor immune systems, current pregnancies, uncontrolled diabetes, lower extremity venous or arterial disease will not be included in this study. After surgery patients will be randomized into two groups. One group will receive a single laser treatment immediately after their surgery on their wound while the other will not. The group not receiving laser therapy will undergo a sham laser therapy treatment. Immediately after therapy and 4, 8, and 12 weeks postoperative patients will have a follow up visit. During these visits patients wound size will be recorded, a photograph will be taken, and the wound temperature will be measured. Patient will be given a diary to record any adverse events related to the wound.

Conditions

Leg Ulcer

Keywords

Leg Ulcer; Lower extremity ulcer; carbon dioxide laser; CO2 Laser; Ablative fractional carbon dioxide lasers

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Completely Healed Lower Extremity Wounds

  Number of participants with completely healed lower extremity wounds by the end of the study (week 12). Complete wound healing is defined by reepithelization of the wound.

  12 weeks (enrollment time per subject)

• Number of Participants Who Experienced Adverse Events.

  Number of participants who experienced adverse events at any time point throughout the study.

  12 weeks (enrollment time per subject)

Secondary Outcomes (2)

• Quality of Life Measure EQ-5D-5L

  12 weeks (enrollment time per subject)

• Wound Temperature Associated With Carbon Dioxide Ablative Fractional Laser for Healing Postoperative Lower Extremity Wounds.

  12 weeks (enrollment time per subject)

Study Arms (2)

Fractional carbon dioxide laser intervention group

EXPERIMENTAL

The intervention will only involve a single treatment with ablative fractional carbon dioxide laser therapy. The investigators will specifically be using the CO2RE® (Syneron Candela Corp, Wayland, MA).

Device: CO2RE® (Syneron Candela Corp, Wayland, MA)

Sham laser intervention group

SHAM COMPARATOR

Other: Sham laser treatment

Interventions

CO2RE® (Syneron Candela Corp, Wayland, MA) DEVICE

The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.

Also known as: Ablative fractional carbon dioxide laser

Fractional carbon dioxide laser intervention group

Sham laser treatment OTHER

A physician who is not blinded will perform a sham laser treatment on blinded subjects.

Sham laser intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years
• Lower extremity wound as a result of Mohs Micrographic Surgery at Saint Louis University Dermatology Des Peres
• A postoperative wound greater than 5 mm in diameter
• Able to understand the informed consent, willing to come to the office for treatments and capable of following post-treatment instructions.

You may not qualify if:

• Pregnancy
• Breast feeding
• Immunosuppression
• Uncontrolled diabetes (defined as \>7% A1c in the last 3 months)
• peripheral vascular disease
• venous insufficiency
• decompensated heart failure (NYHA class IV)
• peripheral neuropathy involving the treatment site
• active cancer at the time of study enrollment excluding curatively treated skin cancer
• Any underlying or current medical condition which, in the opinion of the Investigator, would interfere with the evaluation of the subject. or no desire/unable to undergo laser therapy.
• Immunosuppression will be defined as patients with HIV, AIDS, who have received an organ transplant, allogeneic bone marrow transplant, or peripheral stem cell transplant, and any other patients taking chronic doses of systemic immunosuppressive medication within 6 months prior to randomization. Examples of immunosuppressive medications include Tacrolimus, Azathioprine, Prednisone, or Methotrexate.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (2)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Saint Louis University

St Louis, Missouri, 63122, United States

Location

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MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Ramona Behshad
• Organization: Saint Louis University

ramona.behshad@health.slu.edu

314-977-9721

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Dermatology

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 23, 2018
• Study Start: September 28, 2018
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-12

Locations

US (2)