Effect of Silver Nanoparticles Phonophoresis on Diabetic Foot Ulcer Heeling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Ulcer Surface Area
研究概览
简要总结
This study was conducted to evaluate the effect of silver nanoparticle phonophoresis on accelerating chronic diabetic foot ulcer healing.
详细描述
Silver nanoparticle phonophoresis enhances anti-inflammatory actions by reducing pro-inflammatory cytokines. The effectiveness of topical nanoparticles is constrained due to rapid inactivation by biological debris, making phonophoresis an optimal delivery method, which uses low-intensity ultrasound to penetrate deeply into tissues, enhancing permeability and accelerating healing. The study aimed to evaluate the effect of silver nanoparticle phonophoresis on improving healing in chronic diabetic foot 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type1 or Type 2 Diabetes Mellitus with chronic foot ulcer.
- •Clear clinical documentation of superficial infection.
排除标准
- •Deep bone osteomyelitis.
- •Peripheral gangrene.
- •Severe local ischemia.
- •Pregnancy.
- •Systemic multi-organ failure.
研究组 & 干预措施
Silver nanoparticle phonophoresis and standred care group
The participants received silver nanoparticle phonophoresis in addition to standard care for 3 weeks.
干预措施: Active silver nanoparticle phonophoresis (Device)
Silver nanoparticle phonophoresis and standred care group
The participants received silver nanoparticle phonophoresis in addition to standard care for 3 weeks.
干预措施: Standard wound care (Other)
Isolated therapeutic ultrasound and standard care group
The participants received therapeutic ultrasound followed by topical silver nanoparticles gel in addition to standard care for 3 weeks.
干预措施: Isolated low-intensity pulsed ultrasound therapy (Device)
Isolated therapeutic ultrasound and standard care group
The participants received therapeutic ultrasound followed by topical silver nanoparticles gel in addition to standard care for 3 weeks.
干预措施: Standard wound care (Other)
结局指标
主要结局
Ulcer Surface Area
时间窗: 3 weeks
It was calculated using digital planimetry. A calibration marker was positioned adjacent to the border. The camera of a smartphone having the validated IMITO Wound mobile application was maintained at a distance of 20-30 cm to record the photo and extract ulcer surface area.
Ulcer Volume Displacement Evaluation
时间窗: 3 weeks
It was evaluated by the sterile fluid-injection method. Sterile saline solution was injected into the ulcer cavity via a calibrated syringe. The volume of saline injected was measured to determine volumetric dimensions.
次要结局
未报告次要终点
研究者
Eman Mohammed Hussein
principal investigator
Cairo University