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

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716167
• Other study ID #: IRB00040491
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2018
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: Wake Forest University Health Sciences
• Contact: Renea D Jennings, RN
• Phone: 336-716-6709
• Email: rjenning[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Summus Laser
infrared laser treatment
• Summus Laser Sham
non-infrared light

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

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