RecruitingNot ApplicableNCT03716167

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

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

Sponsor

Wake Forest University Health Sciences

Enrollment

20 participants

Start Date

Jul 27, 2018

Study Type

INTERVENTIONAL

Conditions

Venous Leg Ulcer

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria9

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
\<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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.