Effectiveness of Propolis Phonophoresis on Wound Healing in Diabetic Ulcer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Percentage Reduction in Wound Area
研究概览
简要总结
This study aims to evaluate whether using ultrasound (phonophoresis) can help deliver propolis-a natural compound made by bees-more effectively into the skin to speed up wound healing in people with diabetic foot ulcers. Diabetic foot ulcers are a common and serious complication of diabetes and often take a long time to heal. Propolis has natural anti-inflammatory and antimicrobial properties that may promote healing, but it does not easily penetrate the skin. By using ultrasound to enhance absorption, this study tests whether combining propolis with phonophoresis is more effective than standard wound care alone. Participants will be randomly assigned to receive either the propolis ultrasound therapy or standard care. The study will measure wound size, healing time, pain, infection rates, and quality of life.
详细描述
This randomized, double-blind, controlled clinical trial investigates the therapeutic effectiveness of propolis phonophoresis in treating diabetic foot ulcers (DFUs). DFUs affect approximately 25% of diabetic patients and are associated with high morbidity, prolonged healing, and significant healthcare costs. Propolis, a resinous substance produced by honeybees, has shown antimicrobial, anti-inflammatory, and wound-healing properties in previous studies. However, its limited skin permeability reduces its clinical utility when used topically.
Phonophoresis is a non-invasive technique that uses ultrasound waves to enhance transdermal drug delivery. This study combines a 10% propolis gel with therapeutic ultrasound (1 MHz, 0.5-1.5 W/cm², pulsed mode at 20%) to evaluate its impact on wound healing outcomes compared to standard wound care. The intervention group will receive propolis phonophoresis therapy three times per week for four weeks. The control group will receive standard wound care and a sham ultrasound.
Primary outcome measures include the percentage reduction in wound area, assessed via digital planimetry. Secondary outcomes include time to full wound closure, pain scores, infection rates, and quality-of-life assessments. The study is designed to explore whether this combined therapeutic approach can offer a clinically superior and non-surgical treatment alternative for patients with chronic diabetic ulcers.
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
- Double (Participant, Care Provider)
盲法说明
Participants in both groups receive what appears to be the same treatment procedure. The intervention group receives active ultrasound therapy, while the control group receives a sham (non-therapeutic) ultrasound, keeping both participants and care providers blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years
- •Diagnosed with type 1 or type 2 diabetes mellitus
- •Presence of a diabetic foot ulcer classified as Grade 1 or 2 (Wagner classification)
- •Ulcer size between 1 cm² and 5 cm²
- •Able and willing to provide informed consent
排除标准
- •Severe infection or presence of osteomyelitis at the ulcer site
- •Use of systemic immunosuppressants or corticosteroids
- •Known allergy or hypersensitivity to propolis
- •Pregnant or breastfeeding women
- •Participation in another clinical trial within the past 30 days
研究组 & 干预措施
Experimental: Propolis Phonophoresis
Participants will receive topical application of 10% propolis gel on the diabetic foot ulcer followed by therapeutic ultrasound (phonophoresis) using 1 MHz frequency, 0.5-1.5 W/cm² intensity, pulsed mode (20%), for 5 minutes per session, 3 sessions/week for 4 weeks
.Interventions:
- Drug: Propolis gel (10%)
- Device: Therapeutic ultrasound (phonophoresis)
干预措施: Sham ultrasound (placebo) (Device)
Standard Wound Care + Sham Ultrasound
Participants will receive conventional wound care including debridement, cleaning, and dressing. A sham ultrasound device that emits no therapeutic waves will be applied to simulate the intervention procedure.
Interventions:
- Other: Standard wound care procedures
- Device: Sham ultrasound (placebo)
干预措施: Sham ultrasound (placebo) (Device)
Experimental: Propolis Phonophoresis
Participants will receive topical application of 10% propolis gel on the diabetic foot ulcer followed by therapeutic ultrasound (phonophoresis) using 1 MHz frequency, 0.5-1.5 W/cm² intensity, pulsed mode (20%), for 5 minutes per session, 3 sessions/week for 4 weeks
.Interventions:
- Drug: Propolis gel (10%)
- Device: Therapeutic ultrasound (phonophoresis)
干预措施: Propolis gel (10%) (Drug)
结局指标
主要结局
Percentage Reduction in Wound Area
时间窗: Baseline to Week 4
The primary outcome will be the percentage reduction in the surface area of the diabetic foot ulcer from baseline to the end of the 4-week treatment period. Wound size will be measured using digital planimetry based on standardized wound photographs.
Percentage Reduction in Wound Area
时间窗: Baseline to Week 4
The primary outcome will be the percentage reduction in the surface area of the diabetic foot ulcer from baseline to the end of the 4-week treatment period. Wound size will be measured using digital planimetry based on standardized wound photographs.
次要结局
未报告次要终点
研究者
Amany Gomaa Atiaa
lecturer
Sinai University