Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
RecruitingNot applicableNCT03716167
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers
- Conditions
- Venous Leg Ulcer
- Interventions
- Device: Summus Laser
- Device: Summus Laser Sham
- Sponsor
- Wake Forest University Health Sciences
- Start date
- 2018-07-27
- Primary completion
- 2027-10
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03716167