Laser Therapy for Venous Leg Ulcers

NCT06135246 | Unknown DMC

• 1 other identifier: VLU-HILT-2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percent change in ulcer area from baseline to end of treatment

  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.

  Baseline, 4 weeks, 8 weeks and 12 weeks after randomization

Secondary Outcomes (4)

• Rate of complete ulcer closure at end of treatment

  Single time point at end of study at 12 weeks

• Time to complete ulcer closure

  From baseline (week 0) until complete closure, up to 12 weeks.

• 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

• Incidence of treatment-related adverse events

  From initial treatment until 4 weeks after final treatment, up to 12 weeks total.

Study Arms (2)

Standard Care group

ACTIVE COMPARATOR

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.

Other: Standard Care

High Intensity laser therapy + Standard care group

EXPERIMENTAL

Participants will receive high-intensity laser therapy 3 times per week for 8 weeks or until ulcer closure in addition to standard care.

Device: High Intensity Laser Therapy; Other: Standard Care

Interventions

High Intensity Laser Therapy 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.

Also known as: HILT

High Intensity laser therapy + Standard care group

Standard Care 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; Standard Care group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Amal Fawzy, Ph.D

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Central Study Contacts

Mohamed ElMeligie, Ph.D

CONTACT

01159880001; mmahm1989@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Electromyography lab

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: November 16, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

EG (1)