At a glance
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A Single Center, Prospective, Double-blinded, Randomized, Placebo-controlled Trial Evaluating the Efficacy of Fractionated Carbon Dioxide Therapy in Postoperative Lower Extremity Wound Healing
In Brief
A clinical study evaluating CO2RE® (Syneron Candela Corp, Wayland, MA) and Sham laser treatment for Leg Ulcer. Completed, enrolled 48 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
A physician who is not blinded will perform a sham laser treatment on blinded subjects.