Summus Laser for Venous Leg Ulcer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Venous Leg UlcerSummus Laser - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether laser therapy can provide pain relief and speed healing of venous leg ulcers.

Eligible Conditions
  • Venous Leg Ulcer

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: up to 17 weeks

up to 17 weeks
Infectious complications
Pain measured by survey
Quality of Life Questionnaire
Venous Ulcer rate of healing
Wound aspect
size of venous ulcer

Trial Safety

Trial Design

2 Treatment Groups

Laser Treatment
1 of 2
Sham treatment
1 of 2

Experimental Treatment

Non-Treatment Group

20 Total Participants · 2 Treatment Groups

Primary Treatment: Summus Laser · Has Placebo Group · N/A

Laser Treatment
Device
Experimental Group · 1 Intervention: Summus Laser · Intervention Types: Device
Sham treatment
Device
ShamComparator Group · 1 Intervention: Summus Laser Sham · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 17 weeks

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,127 Previous Clinical Trials
1,137,407 Total Patients Enrolled
Joseph Molnar, MDPrincipal InvestigatorWFUHS

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The pain scale assessment for the study was at or above 2 on the visual analog scale at the initial visit.
An ulcer located on a lower limb in an area of stasis present.
dermatitis The text states that venous insufficiency is documented on the basis of a venous insufficiency ultrasound or on the basis of skin changes consistent with stasis dermatitis.
The ulcer surface is greater or equal to 5 cm2 but no larger than 140 cm2 after the initial debridement.
This means that the person is 18 years or older.