Doubleblinded RCT of the Omnilux on Lower Extremity Surgical Wounds Left to Heal by Second Intention

NCT02383056 | Terminated Results

• 1 other identifier: 20120475
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound

Keywords

wound; secondary intention healing; lower extremity

Outcome Measures

Primary Outcomes (1)

• Number of Days Required for the Wound to Heal Completely

  Assessment by the physician indicating wound closure

  84 days

Secondary Outcomes (2)

• Change in Relative Area of the Surgical Wound Remaining

  Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4

• 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

Study Arms (2)

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

Device: Omnilux Sham

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

Device: Omnilux

Interventions

Omnilux DEVICE

Photomodulation irradiated with a 633 +/- 3 mm light source for 20 minutes (105 mW/cm, 126 J/cm)

Treatment group (Group 2)

Omnilux Sham DEVICE

Sham light instead of phototherapy from the same light device

Sham Group (Group 1)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Dr. Keyvan Nouri
• Organization: University of Miami

Knouri@med.miami.edu

305-243-3380

Study Officials

• Keyvan Nouri, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 9, 2015
• Study Start: December 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 23, 2019
• Results First Posted: May 23, 2019

Record last verified: 2019-05

Locations

US (1)