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Trial record 2 of 2410 for:    CARBON DIOXIDE

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

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ClinicalTrials.gov Identifier: NCT03644849
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ramona Behshad, MD, St. Louis University

Brief Summary:
This study will evaluate the efficacy and safety of laser therapy on postoperative lower extremity wound healing over 12 months. 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 1, 2, 3, 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.

Condition or disease Intervention/treatment Phase
Leg Ulcer Device: CO2RE® (Syneron Candela Corp, Wayland, MA) Other: Sham laser treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Center, Prospective, Double-blinded, Randomized, Placebo-controlled Trial Evaluating the Efficacy of Fractionated Carbon Dioxide Therapy in Postoperative Lower Extremity Wound Healing
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fractional carbon dioxide laser intervention group
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)
The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
Other Name: Ablative fractional carbon dioxide laser

Sham Comparator: Sham laser intervention group Other: Sham laser treatment
A physician who is not blinded will perform a sham laser treatment on blinded subjects.




Primary Outcome Measures :
  1. Safety of the carbon dioxide ablative fractional laser for postoperative lower extremity wounds (Number of adverse events). [ Time Frame: 12 weeks (enrollment time per subject) ]
    Number of adverse events

  2. Tolerability of the carbon dioxide ablative fractional laser for postoperative lower extremity wounds (Score on the EQ-5D-5L) [ Time Frame: 12 weeks (enrollment time per subject) ]
    Score on the EQ-5D-5L. This is a quality of life questionnaire where higher scores equate to a better quality of life.

  3. Pain associated with the carbon dioxide ablative fractional laser for postoperative lower extremity wounds [ Time Frame: 12 weeks (enrollment time per subject) ]
    Pain rated on a 1-10 visual analog scale


Secondary Outcome Measures :
  1. Efficacy of the carbon dioxide ablative fractional laser for healing postoperative lower extremity wounds.(Time, in weeks, till complete wound healing in days) [ Time Frame: 12 weeks (enrollment time per subject) ]
    Time, in weeks, till complete wound healing in days. Complete wound healing is defined by reepithelization of the wound.


Other Outcome Measures:
  1. Wound and peri-wound temperature associated with carbon dioxide ablative fractional laser for healing postoperative lower extremity wounds. [ Time Frame: 12 weeks (enrollment time per subject) ]
    Wound temperature will be recorded in degrees Celsius through an infrared camera.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644849


Locations
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United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Mitchell S Gibbons, BA    417-350-2239    mitchell.gibbons@health.slu.edu   
Sponsors and Collaborators
St. Louis University

Publications:

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Responsible Party: Ramona Behshad, MD, Assistant Professor Department of Dermatology, St. Louis University
ClinicalTrials.gov Identifier: NCT03644849     History of Changes
Other Study ID Numbers: 29076
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ramona Behshad, MD, St. Louis University:
Leg Ulcer
Lower extremity ulcer
carbon dioxide laser
CO2 Laser
Ablative fractional carbon dioxide lasers

Additional relevant MeSH terms:
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Leg Ulcer
Skin Ulcer
Skin Diseases