Recruiting

Near Infrared Laser Therapy

Sponsor:

Wake Forest University Health Sciences

Code:

NCT03716167

Conditions

Venous Leg Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Summus Laser

Summus Laser Sham

Study Details

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

Study ID

NCT03716167

Start date

Jul 27, 2018

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Laser Treatment

Summus Laser treatment with infrared light

sham comparator: Sham treatment

Sham Summus Laser treatment with no infrared light

Interventions

Summus Laser

infrared laser treatment

Summus Laser Sham

non-infrared light

Primary outcome measure

  • Pain measured by survey [ Time Frame: up to 17 weeks ]

Central Contacts and Locations

Central contacts

Renea D Jennings, RN

336-716-6709Renea.Jennings@Advocatehealth.org

Caleb Suggs

336-713-4339Caleb.Suggs@Advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Renea D Jennings, RN

336-716-6709Renea.Jennings@Advocatehealth.org

Caleb Suggs

336-713-4339Caleb.Suggs@Advocatehealth.org

Principal Investigator:

Joseph Molnar, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • laser
  • ulcer
  • wound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-29.