The Efficacy of LL-37 Cream on Aerobic Bacteria Colonization Pattern, Inflammation Response: Interleukin 1α (IL-1α) and Tumor Necrosis Factor α (TNF-α), and Healing Rate of Diabetic Foot Ulcers
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Changes of Healing Rate at 1 Week
研究概览
简要总结
Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of 6.3%. Treatment of diabetic foot ulcer (DFU) is challenging with disappointing outcome. Wound debridement, infection control, pressure relief and revascularization are main pillars of DFU management. Various substances and modalities are being investigated for their potential effects in treating DFU, one of which is LL-37.
In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled. Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream (treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound care. The primary outcomes are the healing rate measured by wound area and granulation index and changes in patterns of aerobic bacteria colonization during the 4-week study duration and changes in concentrations of IL-α and TNF-α from fluid collected from DFU on the end of the second and third week of study compared to baseline.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with DFU
- •Ankle brachial index (ABI) 0.9 - 1.3
- •Wound area 5 - 20 cm^2
- •Wound depth until subcutaneous tissue
- •Without systemic infection, osteomyelitis, septic arthritis, or fasciitis
- •Subjects are willing to participate by signing consent
排除标准
- •On treatment with systemic corticosteroids within 7 days before the start of study
- •On treatment with systemic antibiotics within 2 days before the start of study
- •Patients with end stage renal disease
研究组 & 干预措施
Treatment
0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks
干预措施: LL37 (Drug)
Treatment
0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks
干预措施: Standard Wound Care (Procedure)
Placebo
Placebo cream, administered twice a week for 4 weeks
干预措施: Standard Wound Care (Procedure)
结局指标
主要结局
Changes of Healing Rate at 1 Week
时间窗: Changes from baseline of granulation index at 1 week
Measured by difference of granulation index by ImageJ
Changes of Healing Rate at 2 Week
时间窗: Changes from baseline of granulation index at 2 weeks
Measured by difference of granulation index by ImageJ
Changes of Healing Rate at 3 Week
时间窗: Changes from baseline of granulation index at 3 weeks
Measured by difference of granulation index by ImageJ
Changes of Healing Rate at 4 Week
时间窗: Changes from baseline of granulation index at 4 weeks
Measured by difference of granulation index by ImageJ
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 1 Week
时间窗: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 1 week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 2 Week
时间窗: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 2 week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 3 Week
时间窗: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 3 week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Changes of Aerobic Bacteria Count and Type of Bacteria Species at 4 Week
时间窗: Changes from baseline of the species of bacteria grown on culture and the quantities of their colonies in CFU/swab at 4 week
Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab
Changes of Inflammation Marker at 2 Week
时间窗: Changes from baseline at the end of second week
Measured by the concentrations of IL-α and TNF-α by ELISA
Changes of Inflammation Marker at 3 Week
时间窗: Changes from baseline at the end of third week
Measured by the concentrations of IL-α and TNF-α by ELISA
次要结局
未报告次要终点
研究者
Eliza Miranda, MD
Staff of Tropical Infection Division, Department of Dermatology and Venereology
Fakultas Kedokteran Universitas Indonesia