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

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ClinicalTrials.gov Identifier: NCT03716167
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Device: Summus Laser Device: Summus Laser Sham Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers
Actual Study Start Date : July 27, 2018
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pain measured by survey [ Time Frame: up to 17 weeks ]
    Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable


Secondary Outcome Measures :
  1. Venous Ulcer rate of healing [ Time Frame: up to 17 weeks ]
    healing rate to denote the length of time the patient has a wound

  2. size of venous ulcer [ Time Frame: up to 17 weeks ]
    wound measured length x width x depth

  3. Infectious complications [ Time Frame: up to 17 weeks ]
    Number of events of infectious complications

  4. Wound aspect [ Time Frame: up to 17 weeks ]
    % of granulation tissue

  5. Quality of Life Questionnaire [ Time Frame: up to 17 weeks ]
    Quality of life questions, 0 no trouble or 5 severe trouble


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716167


Contacts
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Contact: Renea D Jennings, RN 336-716-6709 rjenning@wakehealth.edu
Contact: Caleb Suggs 336-713-4339 csuggs@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Renea D Jennings, RN    336-716-6709    rjenning@wakehealth.edu   
Contact: Caleb Suggs    336-713-4339    csuggs@wakehealth.edu   
Principal Investigator: Joseph Molnar, MD         
Principal Investigator: Lucian Vlad, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Joseph Molnar, MD WFUHS
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03716167    
Other Study ID Numbers: IRB00040491
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Wake Forest University Health Sciences:
laser
ulcer
wound
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
 Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases