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
Phase: NA
Conditions: Wound
Sponsor: University of Miami

 
 
 
 DOUBLE-BLINDED, 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 
Amendment #1: 12/10/12 
NCT02383056 
Dr. Keyvan Nouri 
Professor, University of Miami 
 

 
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DOUBLE-BLINDED, 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 
 
Amendment #1: 12/10/12 
 
I. 
INTRODUCTION 
 
The first published data that the LED (Light Emitting Diode) light may be 
beneficial during wound healing occurred during the 18th century by Fubini and 
colleagues.  Their early work on subcellular organelles was confirmed nearly 100 
years later by Tina Karu demonstrating that 633 nm light targeted cytochrome c in 
the mitochondrial electron transport chain.1 Much recent research on LED has 
occurred largely as a result of NASA’s program to develop a light source to grow 
plants on space shuttles.  This recent research has focused on how the LED works 
on biological tissue and its applications to medicine. 
Similar to the 633 nm light emitted by the LED, red light from the HeNe 
633 nm laser has been shown to induce fibroblast monosheet formation faster with 
better alignment when compared to non-irradiated controls.2 The LED, when used 
in the 830 nm range, stimulates macrophages and neutrophils to perform 
chemotactic, phagocytic functions more quickly.  It also increases fibroblast release 
of fibroblast growth factor by nearly 30 times.3-5 Perhaps most intriguingly, 633 nm 
and 830 nm LED light has been shown to stimulate keratinocytes to release a large 
amount of cytokines, and migrate into the dermis to aid in the dermal wound healing 
process.6 These photoactivated keratinocytes improve the cellularity and epidermal 
organization especially in the stratum corneum.7  
 
The 830/633 nm LED has been used to improve wound healing after an 
Er:YAG/CO2 ablative laser system treatment.8  The experimental group received 
the 830/630 nm LED following ablative laser therapy while the control group 
received only the 630 nm LED after ablative laser treatment.  The mean healing 
time for the experimental group was 6 weeks versus 13 weeks for the control group.  
Similarly, another study measured healing time after upper blepharoplasty and 
found healing time to be reduced one-half to one third in the 830/633 nm group.9 
Another study using the LED (830/633 nm) treatment after Er:YAG laser ablation 
of deep plantar warts reduced the healing time by nearly half and reduced post-
operative pain by 10% involving 121 subjects.10  Lower extremity ulcers have also 
been shown to be benefitted in terms of healing times by the 830 nm LED in a pilot 
study.11  
 
Wounds on the lower extremity heal more slowly than wounds on the head 
and neck and can remain deep red or violaceous for six months to one year.12 The 
decision to allow lower extremity wounds to heal by second intention is guided by 
a difficulty in using primary closure in many lower extremity wounds because of 
excess wound tension and limited tissue mobility. Decreased tissue laxity creates 
increased wound tension and an increased likelihood for wound dehiscence. By 
using second intention as a method for surgical defect management the physician 

 
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need not worry about dehiscence and retained suture material serving as a nidus for 
infection. Wound management is simple, requiring only a bandage and daily care 
that can be done at home by the patient, family, or visiting nurse. A major limitation 
of allowing surgical defects on the lower extremity to heal by second intention is 
the long healing time that can often take months. For this reason, modalities that 
can hasten this process are in demand.  
 
 
II.  
OBJECTIVE 
 
The goal of the study is to evaluate the efficacy of the light-emitting diode 
in the treatment of lower extremity surgical wounds left to heal by secondary 
intention by way of a double-blinded randomized, controlled study.  
 
III.  
STUDY PLAN 
 
Patients will be recruited from patients at the University of Miami Miller 
School of Medicine Mohs/Laser Unit. On the day of surgery and wound defect 
creation (day 0), patients will be informed of the study, and given the option of 
participating.  If he or she decides to participate, the patient will be randomized into 
one of two groups in blocks of two by coin flip. The patient will remain blinded to 
the outcome of randomization.  The experimental group will receive treatment with 
the light emitting diode (LED) for one session lasting 20 minutes of exposure at an 
intensity of 105 mW/cm2 for a total of 126 J/cm2 over the wound site. The LED 
emits light at wavelengths of 633 nm and 830 nm at fluences of 126 and 66 J/cm2.   
This study will only utilize the 633 nm wavelength. The control group will receive 
sham light treatment for 20 minutes with standard of care for second intention 
healing and no LED treatment. In this case, 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. 
 
On day 0 the patients will be informed of the study and randomized into one 
of two groups by coin flip to either the experimental or control group. The patients 
will be blinded to which group they have been randomized too. Group 1 is the 
control group, which will receive sham light treatment and standard of care for 
lower extremity wounds. Group 2 represents the experimental group, which will 
receive LED treatment plus standard of care. The experimental group will receive 
treatment with the light emitting diode (LED) at 633 nm at one session lasting 20 
minutes of exposure at an intensity of 105 mW/cm2 for a total of 126 J/cm2 over 
the wound defect, one week after wound creation (+/- 3 days).  The control group 
will receive no LED treatment, however they will be exposed to a sham light for 
the duration of 20 minutes as well as receive standard of care for their lower 
extremity wound. Treatment will occur at one-week intervals (+/- 3 days) for a total 

 
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of 4 treatments for both the experimental and control/sham groups. The wounds 
will be created as a result of Mohs micrographic surgery or surgical excision, and 
left to heal by secondary intention.  An Aranz silhouette camera will be used with 
a measurement stick on the picture. Changes from the baseline wound (including 
length and width) will be measured along with wound depth.  These two parameters 
will be compared at the 1 week, 2 week 3 week, and 4-week treatment (or sham 
treatment) visits. After the 4th and final treatment with the LED or sham light, the 
patients will be followed at 1-week intervals (+/- 3 days) until the wound has closed 
or for a maximum of 3 months, whichever occurs first. Once the wound has closed, 
patients will be evaluated a final time, 1 week after wound closure to ensure that 
complete wound healing has indeed occurred. After this final wound evaluation, 
the patient’s commitment required for this study will end and regular follow-up 
with dermatology will resume outside the scope of this study.  
The clinical photographs taken before and after either LED or sham light 
treatment at each study visit will be evaluated by blinded assessor(s) who are board-
certified dermatologist(s).  
 
IV.  
SUBJECT POPULATION 
 
 
A. 
Number of Subjects 
 
We plan to prospectively enroll 40 patients in this study. 
 
B. 
Inclusion Criteria 
 
Surgical defect on the lower extremity left to heal by secondary intention. 
There is no minimum size for the wound. Women of child-bearing potential 
must be using medically-accepted contraceptive measures in order to 
participate in the study. Patients must be able to complete all study-related 
visits as scheduled. Maximum size of the wound is 5cm x 5cm.  
 
C. 
Exclusion Criteria 
 
Any history of porphyria, photosensitive cutaneous eruptions, diabetes 
mellitus, history of venous insufficiency, or known history of peripheral 
arterial disease as defined by an ABI < 0.8, any ointments or creams 
containing known photosensitizers such as coumarins or porphyrins should 
be discontinued for 2 weeks prior, any systemic or topical retinoids, 
especially isotretinoin, in the past 6 months, current pregnancy or lactating, 
any patient with a history of metastatic cancer. Individuals under the age of 
18 years will also be excluded from the study.  
 
 
V. 
STUDY PROCEDURES 
 

 
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Those patients who have a surgical defect on the lower extremity that will be left 
to heal by secondary intention and are willing to participate in the study will be 
consented and enrolled in the study.  
 
The following information will be recorded in a prospective fashion: Patient’s age, 
gender, race/ethnicity, type of skin cancer removed, clinical size of lesion (mm) 
and size of resulting defect following surgery. It will also be recorded to what 
group, treatment with LED and standard wound care versus sham light treatment 
and standard wound care with no LED. Clinical photos of the lesion will also be 
taken. 
 
The experimental group will receive treatment with the light emitting diode (LED) 
for 20 minutes of exposure at an intensity of 105 mW/cm2 for a total of 126 J/cm2, 
over the wound site.  The LED emits light at wavelengths of 633 nm and 830 nm 
at fluences of 126 and 66 J/cm2.   This study will only utilize the 633 nm 
wavelength. The control group will receive sham light treatment for 20 minutes 
duration and standard of care for second intention healing without the LED 
treatment. This includes maintenance of a clean and moist wound environment. 
Patients will keep the wound covered with an occlusive bandage and will perform 
daily dressing changes. Daily gentle cleansing with soap and water and the 
application of antibacterial ointment as needed for wound hydration will be the 
recommended standard of care for both treatment and control groups. 
 
 
VI. 
 ADVERSE EVENTS 
 
 
The patients enrolled in the study will be treated with the standard of care for lower 
extremity wounds following surgery. There are no potential economic/financial, 
legal, psychological, social or other risks to which research participants may be 
exposed as a result of their participation in this research. Minor physical risks such 
as bleeding and infection are involved with the standard of care procedure. If a 
wound infection occurs the patient will be started on appropriate antibiotic 
therapy.   
 
 
VII. 
STATISTICAL CONSIDERATIONS 
 
This will depend on whether we want to measure a change between the 
experimental and control group at particular time intervals and between groups 
(ANCOVA) OR do we just want to measure the difference between the control and 
experimental groups at particular time periods  (t test).   If we just do a t test, then 
we will not be able to make intragroup comparisons, but it will be very easy to 
analyze, yet still determine if the experimental group accelerates wound healing in 
comparison to the control group.  In addition, we should probably run an unpaired 
t test at baseline to make sure no statistically significant difference exists in wound 

 
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size between the experimental and control groups, otherwise it could confound our 
results one way or the other.   
 
 
 
 
VIII. DATA HANDLING 
 
The records for the study will be kept in a locked room with access limited to 
approved study personnel. The records will be kept at the Sylvester Cancer Center 
Mohs Unit under supervision of Dr. Keyvan Nouri. Access to this computer will be 
password restricted to authorized study personnel only.  
 
IX. SUBECT REIMBURSEMENT AND COSTS 
 
Patients involved in this study will receive no financial or other reimbursement. 
Participants will have no costs associated with this study. 
 
 
X.  
REFERENCES 
 
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