High-intensity laser therapy for healing venous leg ulcers

Efficacy of High-Intensity Laser Therapy in the Management of Venous Leg Ulcers: A Randomized Controlled Trial

This study is testing if high-intensity laser therapy can help people with venous leg ulcers heal faster when combined with standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ahram Canadian University (Academic / other)
• Locations: 1 site (Al Ḩayy Ath Thāmin, Giza)
• Trial ID: NCT06135246 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of high-intensity laser therapy in promoting wound healing for patients with venous leg ulcers. Participants will be randomly assigned to receive either the laser therapy combined with standard care or standard care alone. The laser treatment will be administered three times a week for eight weeks or until the ulcer is fully healed. The primary goal is to measure the proportion of participants achieving complete ulcer closure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with venous leg ulcers of specific size and duration.

Not a fit: Patients with active infections, uncontrolled diabetes, or other specified exclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients suffering from venous leg ulcers.

How similar studies have performed: While this approach is promising, it is not widely tested, making it a novel intervention in this context.

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.

Where this trial is running

Al Ḩayy Ath Thāmin, Giza

• Outpatient clinic of faculty of physical therapy, Ahram Canadian University — Al Ḩayy Ath Thāmin, Giza, Egypt (Recruiting)

Study contacts

• Study coordinator: Mohamed ElMeligie, Ph.D

Conditions Venous Leg Ulcer; Varicose Ulcer; Stasis Ulcer