BridgeMD
New treatment option for Venous Leg Ulcer
Official title Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
ClinicalTrials.gov ID: NCT03716167
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.