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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Summus Laser

    Device

    infrared laser treatment

  • Summus Laser Sham

    Device

    non-infrared light

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Laser TreatmentExperimental treatment 1 intervention
Group B: Sham treatmentSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain measured by survey

Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable

Time frame
up to 17 weeks

Secondary outcomes

1

Venous Ulcer rate of healing

healing rate to denote the length of time the patient has a wound

Time frame
up to 17 weeks
2

size of venous ulcer

wound measured length x width x depth

Time frame
up to 17 weeks
3

Infectious complications

Number of events of infectious complications

Time frame
up to 17 weeks
4

Wound aspect

% of granulation tissue

Time frame
up to 17 weeks

Other outcomes

Sponsors and contacts

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