Laser Therapy for Venous Leg Ulcers

Not Applicable

Recruiting

• Conditions: Venous Leg Ulcer; Varicose Ulcer; Stasis Ulcer
• Interventions: Device: High Intensity Laser Therapy; Other: Standard Care

• Registration Number: NCT06135246
• Lead Sponsor: Ahram Canadian University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study Start: 2023-11-16
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity laser therapy + Standard care group	High Intensity Laser Therapy	Participants will receive high-intensity laser therapy 3 times per week for 8 weeks or until ulcer closure in addition to standard care.
Standard Care group	Standard Care	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.
High Intensity laser therapy + Standard care group	Standard Care	Participants will receive high-intensity laser therapy 3 times per week for 8 weeks or until ulcer closure in addition to standard care.

Primary Outcome Measures

Name	Time	Method
Percent change in ulcer area from baseline to end of treatment	Baseline, 4 weeks, 8 weeks and 12 weeks after randomization	Ulcer area will be measured by tracing the wound perimeter on acetate paper and entering into image analysis software to calculate area in cm2. Percent change in ulcer area will be calculated as (area at end of treatment - area at baseline) / area at baseline x 100.

Secondary Outcome Measures

Name	Time	Method
Time to complete ulcer closure	From baseline (week 0) until complete closure, up to 12 weeks.	Number of days from initial treatment until first point at which complete ulcer closure is achieved and maintained through end of treatment period.
Incidence of treatment-related adverse events	From initial treatment until 4 weeks after final treatment, up to 12 weeks total.	Adverse events will be graded per CTCAE v4.0. Number of participants experiencing each severity grade of adverse event related to study treatment will be reported.
Changes in Quality of life	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	The Cardiff Wound Impact Schedule is a condition-specific quality of life questionnaire designed for patients with chronic wounds. It contains 15 questions assessing physical symptoms and daily living. Each item is rated on a 4-point Likert scale from 1 (never) to 4 (all the time). Total score ranges from 15 to 60, with higher scores indicating poorer quality of life.
Rate of complete ulcer closure at end of treatment	Single time point at end of study at 12 weeks	Complete closure is defined as full re-epithelialization of the ulcer with no drainage. Assessed by clinical examination and tracing wound area as 0cm2. Reported as proportion of participants with complete closure.

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt