Status:
UNKNOWN
Laser Therapy for Venous Leg Ulcers
Lead Sponsor:
Ahram Canadian University
Conditions:
Venous Leg Ulcer
Varicose Ulcer
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Male or female patients aged 18 years up to 65 years.
- Presence of a venous leg ulcer, confirmed by clinical examination and Doppler ultrasound (venous reflux \> 0.5 seconds).
- Ulcer size between 1 cm² and 20 cm² at screening.
- Ulcer duration of at least 4 weeks but not more than 12 months.
- Ankle-brachial index (ABI) ≥ 0.8, assessed by Doppler ultrasound.
- Willing and able to provide informed consent and comply with study procedures.
Exclusion
- Presence of an active infection in the ulcer, confirmed by clinical signs and positive culture results.
- Osteomyelitis, diagnosed by radiographs or magnetic resonance imaging (MRI).
- Patients with a history of uncontrolled diabetes, defined as HbA1c level \> 10%.
- Current or planned use of systemic immunosuppressive drugs or corticosteroids during the study period.
- Pregnant or breastfeeding women.
- Patients with a history of malignancy or photosensitive skin disorders.
- Prior history of skin grafting or flap surgery in the affected area within the past 3 months.
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06135246
Start Date
November 16 2023
End Date
August 1 2024
Last Update
November 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, Egypt, 3221405