Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT03716167
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03716167
Study Brief:
Protocol Section:
NCT03716167