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Completed

NCT Number: NCT07626203

Venous Ulcers and Hyaluronic Acid Phonophoresis

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.

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Key information

Conditions

Venous Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Ulcer of Leg

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinics of Faculty of Physical Therapy ,Cairo University.

Giza, Egypt

About this study

This study aimed to evaluate the efficacy of ultrasound-enhanced hyaluronic acid delivery (phonophoresis) on venous leg ulcer healing. The intervention group (Group A) received hyaluronic acid gel phonophoresis, whereas the comparator group (Group B) received ultrasound followed by topical application of hyaluronic acid gel. Outcomes were assessed after four weeks of treatment. The primary outcome was Percentage Wound Area Reduction (PWAR), defined as the change in wound area over the study period divided by time. The secondary outcomes were epithelialization rate and time-based healing rate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both genders whose ages were between 30 - 70 years.
  • Patients with active venous ulcers (C6) according to CEAP (Clinical manifestations- Etiology- Anatomic distribution-Pathophysiology) classification.
  • clinically proved to be non-infected venous ulcers.
  • Patients receive the traditional physical therapy management for venous ulcers which includes compression therapy and active exercise plus frequent dressing change.
  • Patients suffering from recurrent or failed to heal venous ulcers.

Exclusion criteria

  • Individuals who were confined to bed with life-threatening conditions that could interfere with the study's objectives, such as myocardial infarction, renal failure or autoimmune diseases.
  • Patients who had hyaluronic acid hypersensitivity.
  • Presence of skin disorders or conditions that considered contraindicated for therapeutic US (e.g., cellulitis).

Treatment and study plan

Phonophoresis group (A)

Other

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):

Other

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.

Primary outcomes

  1. Percentage Wound Area Reduction (PWAR)

    Time frame: After 3 sessions per week for 4 weeks

    It is calculated as: [(baseline wound area - post-treatment wound area) ÷ baseline wound area] × 100. Digital wound measurements were obtained at baseline and at week four using the validated imitoMeasure smartphone application (imito AG, Zurich, Switzerland). Standardized image acquisition procedures were followed, with the smartphone camera positioned 20-30 cm from the wound and maintained parallel to the wound surface. A calibration marker (QR code) was placed adjacent to the wound on the same plane before image capture, and a photo was taken once the app recognized the QR code. The operator delineated the wound borders on the photo using their finger then the app generated measurements of area, width, length, and circumference.

Secondary outcomes

  1. Rate of Healing

    Time frame: After 3 sessions per week for 4 weeks

    The healing rate to assess the reduction in wound surface area (WSA) over a specified time interval.

    The formula used was:

    Healing Rate = Change in Wound Surface Area/ Time Period.

    *(Change in WSA= Initial WSA - Final WSA). For this study, the healing rate was calculated over a 4-week period. Healing Rate per 4 Weeks = (WSA at Baseline - WSA at 4 Weeks) / 4. Digital wound measurements were obtained at baseline and at week four using the validated imitoMeasure smartphone application (imito AG, Zurich, Switzerland). Standardized image acquisition procedures were followed, with the smartphone camera positioned 20-30 cm from the wound and maintained parallel to the wound surface. A calibration marker (QR code) was placed adjacent to the wound on the same plane before image capture, and a photo was taken once the app recognized the QR code. The operator delineated the wound borders on the photo using their finger then the app generated measurements of area, width, length, and circumference

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Enhancing Venous Ulcer Healing Via Hyaluronic Acid Phonophoresis: A Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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