Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02383056 · ClinicalTrials.gov registry record · NA
Doubleblinded RCT of the Omnilux on Lower Extremity Surgical Wounds Left to Heal by Second Intention
A NA study, sponsored by University of Miami.
- Terminated
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT02383056 is a NA study that was terminated before completion, run by University of Miami. The registered enrollment target is 14 participants.
The verdict
NCT02383056, a NA study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
The goal of the study is to evaluate the effectiveness of the light-emitting diode (LED) in promoting healing of the wound on lower leg as a result of surgery. Wounds on the lower leg heal more slowly than wounds on the head and neck; they can also remain deep red for six months to one year. Doctors usually allow a lower leg surgical wound to heal by itself, without stitches or other additional treatment. This is because leg wounds do not hold stitches well and stitches could cause other problems. A major drawback of allowing a surgical wound on the lower leg to heal by itself is the long healing time that can often take months. The investigators wish to evaluate if the LED light treatment of the surgical wound will improve the healing of your wound. In order to test if leg wounds heal faster after treatment with LED, half of the patients in the study will receive the LED (Group 2) and half will not receive treatment with LED but will receive a "sham light" treatment (Group 1). Essentially, a sham light treatment refers to regular light (not LED) exposure for 20 minutes. The sham light comes from the same device as the treatment light (Omnilux machine) however, this light has no anticipated effects on wound healing and is used simply to reduce the amount of bias that sometimes complicates the results of these studies. There is no added risk or benefit for the patients in the control group exposed to the sham light. Both groups will receive the standard care of wounds on the lower extremity.
Interventions
- DEVICE Omnilux
- DEVICE Omnilux Sham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-12 |
| Est. Completion | 2017-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02383056
The ClinicalTrials.gov registry entry for NCT02383056 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Omnilux is the first listed.
NCT02383056 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02383056 about?
NCT02383056 is a clinical study titled "Doubleblinded RCT of the Omnilux on Lower Extremity Surgical Wounds Left to Heal by Second Intention". The goal of the study is to evaluate the effectiveness of the light-emitting diode (LED) in promoting healing of the wound on lower leg as a result of surgery. Wounds on the lower leg heal more slowly than wounds on the head and neck; they can also remain deep red for six months to one year. Doctors...
What is the current status of trial NCT02383056?
This trial is currently terminated. It is a NA study. The enrollment target is 14 participants. The study started on 2012-12. Estimated completion is 2017-11.
What interventions are being tested in trial NCT02383056?
The interventions under investigation include: Omnilux (DEVICE), Omnilux Sham (DEVICE).
Who is sponsoring clinical trial NCT02383056?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.