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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Oct 19, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special type of laser therapy to help relieve pain and promote healing in people with chronic venous leg ulcers. These ulcers are often caused by poor blood flow in the legs and can be painful and slow to heal. The laser emits infrared light that warms the skin and underlying tissues, which may help reduce pain and increase blood flow to the area, potentially speeding up the healing process.

To participate in the trial, you need to be at least 18 years old and have a documented condition of venous insufficiency, meaning your veins aren't functioning properly. You should have a leg ulcer that is between 5 and 140 square centimeters in size and has been present for more than four weeks. Participants will undergo assessments to measure their pain and the healing of their ulcers throughout the study. It's important to note that certain conditions, like pregnancy or specific medical treatments, could make someone ineligible to participate. If you meet the criteria and are looking for a new way to manage your pain and promote healing, this trial might be a good option for you.

Gender

ALL

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.