Laser Therapy for Venous Leg Ulcers

Launched by AHRAM CANADIAN UNIVERSITY · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of high-intensity laser therapy on healing venous leg ulcers, which are painful sores that can develop on the legs due to poor blood flow. Participants will be randomly placed into two groups: one will receive laser therapy along with standard care, while the other will only receive standard care. The laser treatments will happen three times a week for up to eight weeks, or until the ulcer completely heals. The main goal of the study is to see how many participants experience complete healing of their ulcers.

To be eligible for this trial, participants must be between 18 and 65 years old and have a venous leg ulcer that has been present for at least four weeks but no longer than 12 months. The ulcer must be a certain size and there should be no active infections or certain other health conditions that could interfere with the study. If you join the trial, you will closely follow the study procedures and may have the chance to benefit from an innovative treatment option. This trial is currently recruiting participants of all genders, so if you or someone you know has a venous leg ulcer, it might be worth considering participation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients aged 18 years up to 65 years.
• • 2. Presence of a venous leg ulcer, confirmed by clinical examination and Doppler ultrasound (venous reflux \> 0.5 seconds).
• • 3. Ulcer size between 1 cm² and 20 cm² at screening.
• • 4. Ulcer duration of at least 4 weeks but not more than 12 months.
• • 5. Ankle-brachial index (ABI) ≥ 0.8, assessed by Doppler ultrasound.
• • 6. Willing and able to provide informed consent and comply with study procedures.
• Exclusion Criteria:
• • 1. Presence of an active infection in the ulcer, confirmed by clinical signs and positive culture results.
• • 2. Osteomyelitis, diagnosed by radiographs or magnetic resonance imaging (MRI).
• • 3. Patients with a history of uncontrolled diabetes, defined as HbA1c level \> 10%.
• • 4. Current or planned use of systemic immunosuppressive drugs or corticosteroids during the study period.
• • 5. Pregnant or breastfeeding women.
• • 6. Patients with a history of malignancy or photosensitive skin disorders.
• • 7. Prior history of skin grafting or flap surgery in the affected area within the past 3 months.