Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT02383056
Status:
TERMINATED
Last Update Posted:
2019-05-23
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Doubleblinded RCT of the Omnilux on Lower Extremity Surgical Wounds Left to Heal by Second Intention
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sufficient enrollment achieved for outcome measures
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: