RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2018-07-27
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03716167

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 yo or older
  2. * Venous insufficiency documented on basis of Venous Insufficiency US or on basis of skin changes c/w stasis
  3. * Ulcer location in area of stasis present on lower limb
  4. * Ulcer surface greater or equal to 5 cm2 but no larger than 140 cm2 after the initial debridement
  5. * Ankle brachial index (ABI) \> 0.8
  6. * Ulcer duration longer than 4 weeks
  7. * Pain scale assessment per visual analog scale at, or above, 2 at initial visit for the study
  1. * Pregnant, nursing or child bearing potential
  2. * Venous ablation past 6 weeks and duration of study
  3. * Autoimmune disorder
  4. * Immune suppressive meds, Including steroids
  5. * Any other co-playing comorbidities into wound etiology (neuropathy with pressure reinjury or uncontrolled diabetes with Hb A1c \> 9)
  6. * Use of bioengineered products 30 days before and during the duration of study
  7. * 15\<BMI \<50
  8. * Use of oral or IV administered antibiotics within one week prior to randomization
  9. * Having tattoos in the region of skin above or adjacent to the ulcer where laser light might be applied.

Contacts and Locations

Study Contact

Renea D Jennings, RN
CONTACT
336-716-6709
rjenning@wakehealth.edu
Caleb Suggs
CONTACT
336-713-4339
csuggs@wakehealth.edu

Principal Investigator

Joseph Molnar, MD
PRINCIPAL_INVESTIGATOR
WFUHS

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Joseph Molnar, MD, PRINCIPAL_INVESTIGATOR, WFUHS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-27
Study Completion Date2026-10

Study Record Updates

Study Start Date2018-07-27
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • laser
  • ulcer
  • wound

Additional Relevant MeSH Terms

  • Venous Leg Ulcer