Clinical trial NCT06135246: Laser Therapy for Venous Leg Ulcers
Official title: Efficacy of High-Intensity Laser Therapy in the Management of Venous Leg Ulcers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Leg Ulcer
Varicose Ulcer
Stasis Ulcer
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will evaluate the effects of high-intensity laser therapy on wound healing in patients with venous leg ulcers. Participants will be randomly assigned to receive either laser therapy plus standard care or standard care alone. The laser therapy will be administered 3 times per week for 8 weeks or until ulcer closure. The primary outcome is proportion of participants with complete ulcer closure.


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.

Primary outcomes:
measure: Percent change in ulcer area from baseline to end of treatment
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks after randomization
Secondary outcomes:
measure: Rate of complete ulcer closure at end of treatment
timeFrame: Single time point at end of study at 12 weeks
measure: Time to complete ulcer closure
timeFrame: From baseline (week 0) until complete closure, up to 12 weeks.
measure: Changes in Quality of life
timeFrame: Change in total score on the Cardiff Wound Impact Schedule will be assessed from baseline (week 0), 4 weeks, 8 weeks and 12 weeks after randomization
measure: Incidence of treatment-related adverse events
timeFrame: From initial treatment until 4 weeks after final treatment, up to 12 weeks total.
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.D
role: STUDY_CHAIR
References: