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

Not Applicable

Recruiting

• Conditions: Venous Leg Ulcer
• Interventions: Device: Summus Laser Sham; Device: Summus Laser

• Registration Number: NCT03716167
• Lead Sponsor: Wake Forest University Health Sciences

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.

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 Timeline

• Study Start: 2018-07-27
• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham treatment	Summus Laser Sham	Sham Summus Laser treatment with no infrared light
Laser Treatment	Summus Laser	Summus Laser treatment with infrared light

Primary Outcome Measures

Name	Time	Method
Pain measured by survey	up to 17 weeks	Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States