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Sufficient enrollment achieved for outcome measures
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Group (Group 1) | Sham Comparator | 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 |
|
| Treatment group (Group 2) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnilux | Device | Photomodulation irradiated with a 633 +/- 3 mm light source for 20 minutes (105 mW/cm, 126 J/cm) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Required for the Wound to Heal Completely | Assessment by the physician indicating wound closure | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Relative Area of the Surgical Wound Remaining | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keyvan Nouri, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Omnilux sham light |
| FG001 | 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 Omnilux: 633nm |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Omnilux sham light |
| BG001 | Treatment Group (Group 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Days Required for the Wound to Heal Completely | Assessment by the physician indicating wound closure | Posted | Mean | Standard Deviation | days | 84 days |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Omnilux sham light |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MeDRA (22.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keyvan Nouri | University of Miami | 305-243-3380 | Knouri@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2012 | Apr 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Omnilux Sham | Device | Sham light instead of phototherapy from the same light device |
|
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 |
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 Omnilux: 633nm |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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|
| Secondary | Change in Relative Area of the Surgical Wound Remaining | Initial area * ((total area in the evaluated week/total area in the first week) * 100) and reported as a percentage (%) | Posted | Mean | Standard Deviation | Percentage of Wound Remaining | Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4 |
|
|
|
| Secondary | Change in Total Surface Area of the Surgical Wound | A blinded investigator manually outlines the wound using a digital planimetry device to measure the surface area in square centimeters. | Posted | Mean | Standard Deviation | Cm^2 | Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4, Week 1 to Week 4 |
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| 0 |
| 7 |
| 0 |
| 7 |
| 3 |
| 7 |
| EG001 | 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 Omnilux: 633nm | 0 | 7 | 0 | 7 | 5 | 7 |
| Pruritis | Skin and subcutaneous tissue disorders | MeDRA (22.0) | Systematic Assessment |
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| Tenderness | Skin and subcutaneous tissue disorders | MeDRA (22.0) | Systematic Assessment |
|
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| Week 3 to Week 4 |
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| Week 3 to Week 4 |
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| Week 1 to Week 4 |
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