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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT03716167
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Summus Laser — DEVICE
    infrared laser treatment
  • Summus Laser Sham — DEVICE
    non-infrared light

Study Details

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.

Key Dates

Start date
Jul 27, 2018
Status verified
Aug 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Laser Treatment
    Summus Laser treatment with infrared light
  • Sham Comparator: Sham treatment
    Sham Summus Laser treatment with no infrared light

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Renea D Jennings, RN
[email protected]
336-716-6709
Caleb Suggs
[email protected]
336-713-4339
Joseph Molnar, MD (PRINCIPAL_INVESTIGATOR)
Lucian Vlad, MD (PRINCIPAL_INVESTIGATOR)

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Wake Forest University Health Sciences· Winston-Salem, NC

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