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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
RECRUITING
Al Ḩayy Ath Thāmin
Contact Information
Primary
Mohamed ElMeligie, Ph.D
mmahm1989@gmail.com
01159880001
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2024-08-01
Participants
Target number of participants: 70
Treatments
Active_comparator: Standard Care group
Participants will receive standard compression bandaging and wound care alone without high-intensity laser therapy. Bandaging will be applied weekly and wound care will be performed as per institutional protocols.
Experimental: High Intensity laser therapy + Standard care group
Participants will receive high-intensity laser therapy 3 times per week for 8 weeks or until ulcer closure in addition to standard care.
Related Therapeutic Areas
Sponsors
Leads: Ahram Canadian University

This content was sourced from clinicaltrials.gov