Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy

Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers

The laser emits an infrared light that heats the skin and underlying tissues with the purpose of temporary relief of minor muscle and joint pain, as well as stiffness associated with arthritis. The laser also causes a temporary increase in blood flow. The purpose of this study is to evaluate whether laser therapy can provide pain relief and speed the healing of venous leg ulcers.

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: Summus Laser; Device: Summus Laser Sham

Detailed Description

The Summus Laser Cube is an FDA cleared light-emitting device for applying infrared to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

There will be a total of 20 subjects involved in this study. The study will only involve participants being treated at the Wake Forest University Health Sciences Wound Care Center. Ten participants will be randomized to the treatment arm and receive therapeutic laser therapy applied to the ulcer area. The other ten participants will receive a sham laser therapy, where the light emitted by the laser is visible, but not powerful enough to provide a therapeutic effect. During the first weekly visit, patients will have the wound debrided (dead or dying tissue will be removed),and the size of the ulcer measured and photographed. A wound dressing will be applied, followed by a compression wrap.

After one week patients will return to the Wound Care clinic and the size of the wound will be evaluated. If the wound has decreased by less than 30%,the patient will be randomized into the protocol. The patient will then have weekly visits, to include a survey, wound measurements, survey, photos,and laser treatments. The length of the study is a maximum of 17 weeks (less if the patient heals faster). The purpose of this study is to evaluate whether laser therapy can provide pain relief and speed the healing of venous leg ulcers.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renea D Jennings, RN; Phone Number: 336-716-6709; Email: rjenning@wakehealth.edu
• Study Contact Backup: Name: Caleb Suggs; Phone Number: 336-713-4339; Email: csuggs@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Renea D Jennings, RN; Phone Number: 336-716-6709; Email: rjenning@wakehealth.edu
      • Contact: Caleb Suggs; Phone Number: 336-713-4339; Email: csuggs@wakehealth.edu
      • Principal Investigator: Joseph Molnar, MD
      • Principal Investigator: Lucian Vlad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 yo or older
• Venous insufficiency documented on basis of Venous Insufficiency US or on basis of skin changes c/w stasis
• Ulcer location in area of stasis present on lower limb
• Ulcer surface greater or equal to 5 cm2 but no larger than 140 cm2 after the initial debridement
• Ankle brachial index (ABI) > 0.8
• Ulcer duration longer than 4 weeks
• Pain scale assessment per visual analog scale at, or above, 2 at initial visit for the study

Exclusion Criteria:

• Pregnant, nursing or child bearing potential
• Venous ablation past 6 weeks and duration of study
• Autoimmune disorder
• Immune suppressive meds, Including steroids
• Any other co-playing comorbidities into wound etiology (neuropathy with pressure reinjury or uncontrolled diabetes with Hb A1c > 9)
• Use of bioengineered products 30 days before and during the duration of study
• 15<BMI <50
• Use of oral or IV administered antibiotics within one week prior to randomization
• Having tattoos in the region of skin above or adjacent to the ulcer where laser light might be applied.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Treatment; Summus Laser treatment with infrared light	Device: Summus Laser; infrared laser treatment
Sham Comparator: Sham treatment; Sham Summus Laser treatment with no infrared light	Device: Summus Laser Sham; non-infrared light

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain measured by survey	Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable	up to 17 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous Ulcer rate of healing	healing rate to denote the length of time the patient has a wound	up to 17 weeks
size of venous ulcer	wound measured length x width x depth	up to 17 weeks
Infectious complications	Number of events of infectious complications	up to 17 weeks
Wound aspect	% of granulation tissue	up to 17 weeks
Quality of Life Questionnaire	Quality of life questions, 0 no trouble or 5 severe trouble	up to 17 weeks

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Joseph Molnar, MD, WFUHS

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2018
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: laser; wound; ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: IRB00040491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No