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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: Completed NA study of Leg Ulcer, sponsored by St. Louis University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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.

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

FieldValue
Enrollment Target 48 participants
Start Date 2018-09-28
Est. Completion 2020-11-19
Phase NA
St. Louis University

107 total trials

What the finished NCT03644849 record still lists

NCT03644849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 37,715-participant average among 8 other Leg Ulcer trials with a reported enrollment target (100% lower).

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 a single indexed study location in 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.

Similar trials for Leg Ulcer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03644849's enrollment target sits among peer trials

48 7th of 8 higher than 1 of 8 other Leg Ulcer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Leg Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03644849, the US trial registry maintained by the National Library of Medicine. NCT03644849 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.