N/A
N=48
Evaluating the Safety and Efficacy of Fractionated Carbon Dioxide Therapy in Postoperative Lower Extremity Wound Healing
Leg Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03644849 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants With Completely Healed Lower Extremity Wounds — 20; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CO2RE® (Syneron Candela Corp, Wayland, MA) (Device); Sham laser treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Louis University
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Completely Healed Lower Extremity Wounds |
20; 18 | — |
| PRIMARY Number of Participants Who Experienced Adverse Events. |
4; 2 | — |
| SECONDARY Quality of Life Measure EQ-5D-5L |
90.7; 87.5 | — |
| SECONDARY Wound Temperature Associated With Carbon Dioxide Ablative Fractional Laser for Healing Postoperative Lower Extremity Wounds. |
32.41; 31.76 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03644849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.