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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Venous Leg Ulcer
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Wake Forest University Health Sciences,

Joseph Molnar, MD, PRINCIPAL_INVESTIGATOR, WFUHS

Study Record Dates

2026-10