Laser Therapy for Venous Leg Ulcers

NCT ID: NCT06135246

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2024-08-01

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.

Conditions

Venous Leg Ulcer; Varicose Ulcer; Stasis Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

Participants will receive standard compression bandaging and wound care as per institutional protocols, without any laser therapy. The compression bandaging protocol is based on recommendations from the American Venous Forum and American College of Phlebology guidelines (O'Donnell et al., 2014). Multi-layer compression bandages will be applied weekly by trained nurses, with layers including orthopedic padding, elastic bandages, and cohesive bandages. Bandages will be applied with high pressure at the ankle gradually decreasing up the leg, with an ankle pressure of approximately 40 mmHg (Mosti et al., 2015).

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.

Group Type: EXPERIMENTAL

High Intensity Laser Therapy

Intervention Type: DEVICE

Participants will receive high-intensity laser therapy using an 810nm continuous wave diode laser (Multiwave locked System (MlS) provided by aSa). The laser applicator has a flat top hat beam profile with a spot size of 1cm2. The laser will be delivered in direct contact mode perpendicularly to the ulcer surface. Each 1cm2 area of the venous ulcer and a 1cm margin of periwound skin will be treated sequentially using a overlapping grid pattern to cover the entire ulcer area, with a 1 second exposure time per point. This results in a laser energy density of 4J/cm2 delivered to each point.

Standard Care

Intervention Type: OTHER

Participants will receive standard compression bandaging and wound care as per institutional protocols, without any laser therapy. The compression bandaging protocol is based on recommendations from the American Venous Forum and American College of Phlebology guidelines (O'Donnell et al., 2014). Multi-layer compression bandages will be applied weekly by trained nurses, with layers including orthopedic padding, elastic bandages, and cohesive bandages. Bandages will be applied with high pressure at the ankle gradually decreasing up the leg, with an ankle pressure of approximately 40 mmHg (Mosti et al., 2015).

Interventions

High Intensity Laser Therapy

Participants will receive high-intensity laser therapy using an 810nm continuous wave diode laser (Multiwave locked System (MlS) provided by aSa). The laser applicator has a flat top hat beam profile with a spot size of 1cm2. The laser will be delivered in direct contact mode perpendicularly to the ulcer surface. Each 1cm2 area of the venous ulcer and a 1cm margin of periwound skin will be treated sequentially using a overlapping grid pattern to cover the entire ulcer area, with a 1 second exposure time per point. This results in a laser energy density of 4J/cm2 delivered to each point.

Intervention Type: DEVICE

Standard Care

Participants will receive standard compression bandaging and wound care as per institutional protocols, without any laser therapy. The compression bandaging protocol is based on recommendations from the American Venous Forum and American College of Phlebology guidelines (O'Donnell et al., 2014). Multi-layer compression bandages will be applied weekly by trained nurses, with layers including orthopedic padding, elastic bandages, and cohesive bandages. Bandages will be applied with high pressure at the ankle gradually decreasing up the leg, with an ankle pressure of approximately 40 mmHg (Mosti et al., 2015).

Intervention Type: OTHER

Other Intervention Names

HILT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahram Canadian University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Magdy ElMeligie

Director of Electromyography lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Fawzy, Ph.D

Role: STUDY_CHAIR

Faculty of Physical Therapy, Ahram Canadian University

Locations

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed ElMeligie, Ph.D

Role: CONTACT

mmahm1989@gmail.com

01159880001

Facility Contacts

Mohamed M ElMeligie, Ph.d

Role: primary

mohamed.elmeligie@acu.edu.eg

01064442032

Other Identifiers

VLU-HILT-2023

Identifier Type: -

Identifier Source: org_study_id