Trial Outcomes & Findings for Doubleblinded RCT of the Omnilux on Lower Extremity Surgical Wounds Left to Heal by Second Intention (NCT NCT02383056)

NCT ID: NCT02383056

Last Updated: 2019-05-23

Results Overview

Assessment by the physician indicating wound closure

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 84 days
• Results posted on: 2019-05-23

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	7	7
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	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	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
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Sham Group (Group 1) n=7 Participants 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	Treatment Group (Group 2) n=7 Participants 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	Total n=14 Participants Total of all reporting groups
Age, Continuous	69.3 years STANDARD_DEVIATION 7.39 • n=7 Participants	72.6 years STANDARD_DEVIATION 5.41 • n=7 Participants	71.0 years STANDARD_DEVIATION 6.40 • n=14 Participants
Sex: Female, Male Female	2 Participants n=7 Participants	4 Participants n=7 Participants	6 Participants n=14 Participants
Sex: Female, Male Male	5 Participants n=7 Participants	3 Participants n=7 Participants	8 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 84 days

Assessment by the physician indicating wound closure

Outcome measures

Measure	Sham Group (Group 1) n=6 Participants 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	Treatment Group (Group 2) n=5 Participants 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
Number of Days Required for the Wound to Heal Completely	48.67 days Standard Deviation 11.10	63.20 days Standard Deviation 12.20

SECONDARY outcome

Timeframe: 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 (%)

Outcome measures

Measure	Sham Group (Group 1) n=6 Participants 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	Treatment Group (Group 2) n=5 Participants 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
Change in Relative Area of the Surgical Wound Remaining Week 1 to Week 2	90.80 Percentage of Wound Remaining Standard Deviation 19.40	96.0 Percentage of Wound Remaining Standard Deviation 23.70
Change in Relative Area of the Surgical Wound Remaining Week 2 to Week 3	60.70 Percentage of Wound Remaining Standard Deviation 8.71	77.40 Percentage of Wound Remaining Standard Deviation 5.76
Change in Relative Area of the Surgical Wound Remaining Week 3 to Week 4	53.10 Percentage of Wound Remaining Standard Deviation 17.0	45.98 Percentage of Wound Remaining Standard Deviation 20.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Group (Group 1) n=6 Participants 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	Treatment Group (Group 2) n=5 Participants 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
Change in Total Surface Area of the Surgical Wound Week 2 to Week 3	-0.93 Cm^2 Standard Deviation 0.82	-0.48 Cm^2 Standard Deviation 0.44
Change in Total Surface Area of the Surgical Wound Week 3 to Week 4	-0.27 Cm^2 Standard Deviation 0.60	-0.80 Cm^2 Standard Deviation 0.34
Change in Total Surface Area of the Surgical Wound Week 1 to Week 4	-1.38 Cm^2 Standard Deviation 1.03	-1.53 Cm^2 Standard Deviation 0.12
Change in Total Surface Area of the Surgical Wound Week 1 to Week 2	-0.18 Cm^2 Standard Deviation 0.57	-0.25 Cm^2 Standard Deviation 0.62

Adverse Events

Sham Group (Group 1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Treatment Group (Group 2)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sham Group (Group 1) n=7 participants at risk 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	Treatment Group (Group 2) n=7 participants at risk 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
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/7 • 4 months	14.3% 1/7 • 4 months
Skin and subcutaneous tissue disorders Erythema	42.9% 3/7 • 4 months	71.4% 5/7 • 4 months
Skin and subcutaneous tissue disorders Tenderness	0.00% 0/7 • 4 months	14.3% 1/7 • 4 months

Additional Information

Dr. Keyvan Nouri

University of Miami

Phone: 305-243-3380

Email: Knouri@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place