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

NCT03716167 | Recruiting FDA Device

• 1 other identifier: IRB00040491
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Leg Ulcer

Keywords

laser; ulcer; wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Venous Ulcer rate of healing

  up to 17 weeks

• size of venous ulcer

  up to 17 weeks

• Infectious complications

  up to 17 weeks

• Wound aspect

  up to 17 weeks

• Quality of Life Questionnaire

  up to 17 weeks

Study Arms (2)

Laser Treatment

EXPERIMENTAL

Summus Laser treatment with infrared light

Device: Summus Laser

Sham treatment

SHAM COMPARATOR

Sham Summus Laser treatment with no infrared light

Device: Summus Laser Sham

Interventions

Summus Laser DEVICE

infrared laser treatment

Laser Treatment

Summus Laser Sham DEVICE

non-infrared light

Sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \<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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Molnar, MD

  WFUHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renea D Jennings, RN

CONTACT

336-716-6709; rjenning@wakehealth.edu

Caleb Suggs

CONTACT

336-713-4339; csuggs@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: July 27, 2018
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)