Doubleblinded RCT of the Omnilux on Lower Extremity Surgical Wounds Left to Heal by Second Intention

May 2, 2019 updated by: Keyvan Nouri, University of Miami

Doubleblinded, Randomized, Controlled Trial to Study the Effect of Omnilux Light Emitting Diode on Wound Healing Following 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 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Group 2 of this study will receive the LED 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.

Groups 1 and 2 will receive 4 sham light or treatment sessions, respectively (one session every week for 4 weeks). After these sessions are done, all subjects will continue weekly follow up visits until the wound is closed, or 3 months after the surgery have passed; which ever happens first.

One final follow up visit will occur 1 week after the wound closed.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgical defect on the lower extremity left to heal by secondary intention.
  • If women of child bearing potential, contraceptive measures should be used
  • Maximum size of wound is 5cm x5cm; there is no minimum size for the wound.

Exclusion Criteria:

  • History of porphyria photosensitive eruptions, diabetes mellitus, history of venous insufficiency, known history of peripheral arterial disease (ABI <0.8)
  • Use of any ointments or creams containing photosensitizers (coumarins or porphyrins) should be discontinued for 2 weeks prior
  • Use of systemic or local retinoids for the past 6 months.
  • Current pregnancy or breastfeeding
  • History of metastatic cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Group (Group 1)
This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes
Device: Omnilux Sham
Sham light instead of phototherapy from the same light device
Experimental: Treatment group (Group 2)
This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes
Device: Omnilux
Photomodulation irradiated with a 633 +/- 3 mm light source for 20 minutes (105 mW/cm, 126 J/cm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days Required for the Wound to Heal Completely
Time Frame: 84 days
Assessment by the physician indicating wound closure
84 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Relative Area of the Surgical Wound Remaining
Time Frame: Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4
Initial area * ((total area in the evaluated week/total area in the first week) * 100) and reported as a percentage (%)
Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4
Change in Total Surface Area of the Surgical Wound
Time Frame: Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4, Week 1 to Week 4
A blinded investigator manually outlines the wound using a digital planimetry device to measure the surface area in square centimeters.
Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4, Week 1 to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120475

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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