NCT03716167 Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
| NCT ID | NCT03716167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Venous Leg Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2018-07-27 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2018-07-27 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Joseph Molnar, MD
PRINCIPAL INVESTIGATOR
WFUHS
Frequently Asked Questions
Who can join the NCT03716167 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Leg Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03716167 currently recruiting?
Yes, NCT03716167 is actively recruiting participants. Contact the research team at rjenning@wakehealth.edu for enrollment information.
Where is the NCT03716167 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT03716167 clinical trial?
NCT03716167 is sponsored by Wake Forest University Health Sciences. The principal investigator is Joseph Molnar, MD at WFUHS. The trial plans to enroll 20 participants.