Cellular Proliferation, Dermal Repair, and Microbiological Effectiveness of Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change From Baseline Collagen Formation (Collagen Content ) at 6 Weeks
研究概览
简要总结
The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement. A randomized controlled trial was performed involving outpatients with complicated diabetic foot ulcers that either received surgical debridement or UAW debridement every week during a six-week treatment period.
详细描述
- Methods
2.1. Trial design
A randomized and controlled parallel clinical trial was performed involving outpatients with complicated DFU that were admitted to specialized diabetic foot unit between November 2017 to December 2019. The study protocol received full approval from the Ethics Committee of the Hospital Clínico San Carlos, Madrid, Spain (C.P. - C.I. 16/484-P). Each patient provided written informed consent before inclusion.
2.1. Intervention
Participants were randomized and assigned to receive either surgical debridement or UAW debridement every week during a six-week treatment period.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Male and female patients ≥18 years old
- •Type 1 or type 2 diabetes with levels of HbA1c≤85.8 mmol/mol (10%) within 30 days of the beginning of the study
- •Wound stages IB, IIB, ID, and IID according to the University of Texas Diabetic Wound Classification [11]
- •Wound duration of 1-24 months
- •Wound size between 1-30 cm2 after debridement
- •Clinical picture of wounds showing mild or moderate infection, according to the criteria of the Infectious Disease Society of America Guidelines [12] and the European Wound Management Association (EWMA) [13]
- •Ankle-brachial index (ABI) ≤0.9 and ankle systolic blood pressure (ASBP) ≥70mmHg, or toe systolic blood pressure (TSBP) ≥50mmHg, ABI>0.9, TSBP ≥50mmHg and toe-brachial index (TBI) ≤0.7
排除标准
- •• Chronic renal disease or dialysis
- •Non-treated osteomyelitis
- •Necrotizing soft tissue infections
- •Critical limb ischaemia patients with ABI≤0.5 and ASBP<70mmHg or <50mmHg
- •Life expectancy <6 months due to malignant DFU
- •Pregnancy and lactation
- •Patients diagnosed with hepatitis or human immunodeficiency virus (HIV)
- •Patients showing local or systemic conditions that may impair tissue repair
研究组 & 干预措施
Ultrasound Group (UAW group)
UAW debridement was performed using an UAW SONOCA 185 device (Söring GmbH, Germany). The UAW device generates an ultrasound low frequency of 25kHz and is equipped with three UAW instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth, which ranges from superficial to deep. The UAW instrument piezoelectrically transforms the electrical energy delivered from the UAW device into mechanical oscillations in the sonotrode tip. For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern.
干预措施: Ultrasound group (Procedure)
Surgical group
All debridement procedures were performed by the same surgeon (J.L.M.), who is specialist in diabetic foot surgery with more than 20 years of experience.
Surgical debridement involved removal of all necrotic and devitalized tissue that was incompatible with healing, as well as surrounding callus.
干预措施: Surgical group (Procedure)
结局指标
主要结局
Change From Baseline Collagen Formation (Collagen Content ) at 6 Weeks
时间窗: At week zero and week 6
Massons's trichome staining was used to differentiate collagen content from other components, such as muscle fibrin and erythrocytes, in tissue samples. Collagen content was scored according to the following scale: 0 (absent), 1 (mild), 2 (moderate) and 3 (severe). Higher scores mean a better outcome.
Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks
时间窗: At week zero and week 6
Sections of tissue were immunohistochemically-stained with the CD31 marker. Light microscopy was used to count the number of microvessels/endothelial cells in a standardized grid, with the results expressed as microvessel density (Leica DMD 800 morphometric system). Microvessel density was scored according to the following scale: 0 (absent), 1 (low, at least one microvessel), 2 (moderate) and 3 (more than two micro vessels). Higher scores mean a better outcome
Change From Baseline Myofibroblasts Formation (Myofibroblasts Content) at 6 Weeks
时间窗: At week zero and week 6
Actin staining was used to evaluate the presence of myofibroblasts involved in wound healing. These cells increase in number during wound healing. The number of stained cells was semi-quantitatively analyzed using a 0 - 3 scaling score (0= no myofibroblasts, 1= myofibroblasts in low quantity, 2= myofibroblasts in moderate quantity, 3= myofibroblasts in high quantity)
次要结局
- Comparison of Quantitative Microbiological Analysis (Bacterial Counts Expressed Colony-forming Units Per Gram of Tissue) (CFU/g)(At week zero and week 6)
- Wound Score at 6 Weeks(Six weeks)
- Wound Size(6 weeks)
研究者
Jose Luis Lazaro Martinez
Prof.Dr
Universidad Complutense de Madrid