Enhancing Venous Ulcer Healing Via Hyaluronic Acid Phonophoresis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究者
Fatma Helmy Elmlegy
Master of Physical Therapy for Surgery, Cairo University, Egypt
Cairo University