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Completed NCT07626203

Venous Ulcers and Hyaluronic Acid Phonophoresis

Conditions: Venous Ulcer, Venous Ulcer of Leg

Sex: All
Ages: 30 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: Cairo University

Location: Outpatient Clinics of Faculty of Physical Therapy ,Cairo University. Giza

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.

Eligibility Criteria

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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07626203). StuddyBuddy aggregates publicly available trial information.