Venous Ulcers and Hyaluronic Acid Phonophoresis

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.

Conditions

• Venous Ulcer
• Venous Ulcer of Leg

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• HESHAM GALAL MAHRAN, Professor of PT · Faculty of Physical Therapy, department of physical therapy for surgery, Cairo University, Egypt

• SHAIMAA MOHAMED ELSAYEH, Ass. Prof. of PT · Faculty of Physical Therapy, department of physical therapy for surgery, Cairo University, Egypt

• WALIED MOHAMED KHEREBA, Prof. vascular surgery · Faculty of medicine, department of vascular and endovascular surgery, AL-Azhar University New Damietta, Egypt

• Rasha S Farag, MSc · Damietta Directorate for Health Affairs

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-12

Primary Completion

2025-02-20

Completion

2025-02-26

Countries

• Egypt

Study Locations