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Venous Ulcers and Hyaluronic Acid Phonophoresis
Sponsor: Cairo University
Summary
Venous leg ulcers are severe manifestations of chronic venous insufficiency and account for a large proportion of lower limb ulcers. They typically occur below the knee, persist for more than six weeks, and are associated with significant impairment in quality of life and substantial socioeconomic burden. A major clinical challenge is their high recurrence rate, which can reach 50-70% within six months, making treatment resource-intensive and requiring multidisciplinary care. Therapeutic ultrasound and phonophoresis have been proposed to enhance wound healing by promoting tissue repair and improving transdermal drug delivery, including hyaluronic acid, which supports extracellular matrix restoration and wound healing. However, despite the theoretical advantages of combining ultrasound with hyaluronic acid, robust clinical evidence for its effectiveness in venous leg ulcers remains limited. The study aimed to assess the effect of ultrasound-enhanced hyaluronic acid delivery on venous ulcer healing compared to ultrasound followed by topical application of hyaluronic acid.
Official title: Enhancing Venous Ulcer Healing Via Hyaluronic Acid Phonophoresis: A Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
30 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2024-12-12
Completion Date
2025-02-26
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
Phonophoresis group (A)
For Study Group (A): A layer of 0.2% topical hyaluronic acid gel was applied to cover and fill the wound cavity . A sterile glove filled with ultrasound gel was, then secured to the wound with surgical plaster, and ultrasound therapy was applied concurrently. The ultrasound was delivered for 1 minute per 1 cm² of the wound. The parameters used were 0.5 W/cm², low intensity, 1 MHz frequency, and pulsed mode with a 20% duty cycle, adjusted based on the ulcer size. The gel was removed, and the wound was dried and cleaned with saline and the US head with alcohol after each session. The treatment period lasted 4 weeks, with three sessions per week.
Ultrasound-preceded gel (hyaluronic acid gel) group (B):
Pulsed TUS was applied to the wound area at identical parameters to Group A (0.5 W/cm², 1 MHz, 20% duty cycle, one minute per cm²). Immediately following the TUS session, 0.2% HA gel was applied topically to the wound surface. Standard wound care was delivered as described for Group A. Treatment frequency and duration were identical to Group A.
Locations (1)
Outpatient Clinics of Faculty of Physical Therapy ,Cairo University.
Giza, Egypt