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NCT03644849 · ClinicalTrials.gov registry record · NA
Evaluating the Safety and Efficacy of Fractionated Carbon Dioxide Therapy in Postoperative Lower Extremity Wound Healing
A NA study of Leg Ulcer, sponsored by St. Louis University.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 2
- Study locations
NCT03644849 is a NA study of Leg Ulcer that has completed, run by St. Louis University. The registered enrollment target is 48 participants, below the 37,715-participant average among 8 other Leg Ulcer trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03644849, a NA study of Leg Ulcer, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DEVICE CO2RE® (Syneron Candela Corp, Wayland, MA)
- OTHER Sham laser treatment
Study Locations (2)
Missouri
- Saint Louis University - St Louis
- Saint Louis University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-09-28 |
| Est. Completion | 2020-11-19 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03644849
The ClinicalTrials.gov registry entry for NCT03644849 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 37,715-participant average among 8 other Leg Ulcer trials with a reported enrollment target (100% lower). The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Leg Ulcer appearing as the primary indexed condition, and to 2 interventions - of which CO2RE® (Syneron Candela Corp, Wayland, MA) is the first listed.
NCT03644849 reports 2 study locations spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03644849 about?
NCT03644849 is a clinical study titled "Evaluating the Safety and Efficacy of Fractionated Carbon Dioxide Therapy in Postoperative Lower Extremity Wound Healing". 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 pregnancie...
What is the current status of trial NCT03644849?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2018-09-28. Estimated completion is 2020-11-19.
What conditions does trial NCT03644849 study?
This clinical trial studies the following conditions: Leg Ulcer.
What interventions are being tested in trial NCT03644849?
The interventions under investigation include: CO2RE® (Syneron Candela Corp, Wayland, MA) (DEVICE), Sham laser treatment (OTHER).
Who is sponsoring clinical trial NCT03644849?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03644849 being conducted?
This trial has 2 study locations across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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