Wound
Conditions
Keywords
wound, secondary intention healing, lower extremity
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.
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.
Interventions
DEVICEOmnilux
Photomodulation irradiated with a 633 +/- 3 mm light source for 20 minutes (105 mW/cm, 126 J/cm)
DEVICEOmnilux Sham
Sham light instead of phototherapy from the same light device
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Required for the Wound to Heal Completely | 84 days | Assessment by the physician indicating wound closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Relative Area of the Surgical Wound Remaining | 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 (%) |
| Change in Total Surface Area of the Surgical Wound | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 7 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Sham Group (Group 1) | Treatment Group (Group 2) | Total |
|---|---|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 7.39 | 72.6 years STANDARD_DEVIATION 5.41 | 71.0 years STANDARD_DEVIATION 6.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 3 / 7 | 5 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Number of Days Required for the Wound to Heal Completely
Assessment by the physician indicating wound closure
Time frame: 84 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Group (Group 1) | Number of Days Required for the Wound to Heal Completely | 48.67 days | Standard Deviation 11.1 |
| Treatment Group (Group 2) | Number of Days Required for the Wound to Heal Completely | 63.20 days | Standard Deviation 12.2 |
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 (%)
Time frame: Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Group (Group 1) | Change in Relative Area of the Surgical Wound Remaining | Week 3 to Week 4 | 53.10 Percentage of Wound Remaining | Standard Deviation 17 |
| Sham Group (Group 1) | Change in Relative Area of the Surgical Wound Remaining | Week 1 to Week 2 | 90.80 Percentage of Wound Remaining | Standard Deviation 19.4 |
| Sham Group (Group 1) | Change in Relative Area of the Surgical Wound Remaining | Week 2 to Week 3 | 60.70 Percentage of Wound Remaining | Standard Deviation 8.71 |
| Treatment Group (Group 2) | Change in Relative Area of the Surgical Wound Remaining | Week 3 to Week 4 | 45.98 Percentage of Wound Remaining | Standard Deviation 20.5 |
| Treatment Group (Group 2) | Change in Relative Area of the Surgical Wound Remaining | Week 1 to Week 2 | 96.0 Percentage of Wound Remaining | Standard Deviation 23.7 |
| Treatment Group (Group 2) | Change in Relative Area of the Surgical Wound Remaining | Week 2 to Week 3 | 77.40 Percentage of Wound Remaining | Standard Deviation 5.76 |
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.
Time frame: Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4, Week 1 to Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Group (Group 1) | Change in Total Surface Area of the Surgical Wound | Week 1 to Week 2 | -0.18 Cm^2 | Standard Deviation 0.57 |
| Sham Group (Group 1) | Change in Total Surface Area of the Surgical Wound | Week 2 to Week 3 | -0.93 Cm^2 | Standard Deviation 0.82 |
| Sham Group (Group 1) | Change in Total Surface Area of the Surgical Wound | Week 3 to Week 4 | -0.27 Cm^2 | Standard Deviation 0.6 |
| Sham Group (Group 1) | Change in Total Surface Area of the Surgical Wound | Week 1 to Week 4 | -1.38 Cm^2 | Standard Deviation 1.03 |
| Treatment Group (Group 2) | Change in Total Surface Area of the Surgical Wound | Week 1 to Week 4 | -1.53 Cm^2 | Standard Deviation 0.12 |
| Treatment Group (Group 2) | Change in Total Surface Area of the Surgical Wound | Week 1 to Week 2 | -0.25 Cm^2 | Standard Deviation 0.62 |
| Treatment Group (Group 2) | Change in Total Surface Area of the Surgical Wound | Week 3 to Week 4 | -0.80 Cm^2 | Standard Deviation 0.34 |
| Treatment Group (Group 2) | Change in Total Surface Area of the Surgical Wound | Week 2 to Week 3 | -0.48 Cm^2 | Standard Deviation 0.44 |