About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnant, nursing or child bearing potential
Venous ablation past 6 weeks and duration of study
Autoimmune disorder
Immune suppressive meds, Including steroids
Trial design
Parallel
Treatments tested in this trial
Summus Laser
Deviceinfrared laser treatment
Summus Laser Sham
Devicenon-infrared light
Treatment groups
Trial outcomes
Primary outcomes
Pain measured by survey
Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable
Secondary outcomes
Venous Ulcer rate of healing
healing rate to denote the length of time the patient has a wound
size of venous ulcer
wound measured length x width x depth
Infectious complications
Number of events of infectious complications
Wound aspect
% of granulation tissue
Sponsors and contacts
Click on the lead sponsor to view all of their trials.