A Randomized, Parallel, Multi-center, Double Blind, Double Arm, Comparative, Pilot Study to Evaluate the Efficacy and Safety of Wound Healing Topical Spray in Patients withDiabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of subjects with complete healing of ulcer.
研究概览
简要总结
Diabetes-related foot disease (DFD) is a serious public health issue that results in asignificant burden on healthcare resources and that severely impacts the quality of life ofindividuals (Schaper NC. Et.al, 2020, Hinchliffe RJ et.al, 2020). Globally, about 83 to 148million people with diabetes (19–34% of the total population with diabetes) are expectedto develop a foot ulcer in their lifetime (Armstrong DG et.al, 2017). Half of these footulcers become infected (Lavery LA et.al, 2003), with over 15% requiring lower-extremityamputation (Ramsey SD et.al., 1999). DFD is a major cause of hospitalisation worldwide,which is mainly due to the lower limb amputation resulting from the disease (ArmstrongDG et.al, 2017, Kerr M. et.al., 2019)The conventional treatment for DFU consist of weekly ulcer cleansing with saline,debridement using a surgical blade, maintenance of a moist environment, and coveringwith sterile gauzes. In addition, patients are instructed to perform daily cleansing withsaline-moistened gauzes and offloading the affected extremity. While most of these ulcerscan heal successfully, some remain nonhealing, leading to serious and debilitatingcomplications necessitating amputation of affected limb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male/female of ≥18 and ≤75 years of age.
- •2.Patient who can and willing to provide written Informed Consent.
- •Patient with a history of type 2 diabetes mellitus
- •4.Patient having Random Blood Sugar [RBG] Ë‚ 250 mg/dL, on standard antidiabetic treatment.
- •Patient having glycosylated hemoglobin (HbA1c) of less than 12% (based on the existing reports).
- •6.Patient with at least ONE but not more than THREE DFU with wound surface area measured between 1 cm2 and 12 cm2 and depth post-debridement between 1cm2 -2cm2 , on the day of randomization (wound surface area measured by greatest length, greatest width).
- •7.Patient with ulcer located at or below malleolar region of foot and Superficial ulcer, Ulcer without infection, mild and moderate infection.
- •Stage I-A, II-A or I-B on University of Texas wound classification system.
排除标准
- •1.Patient Ë‚ 18 or ˃ 75 years of age.
- •Pregnant and/or nursing woman.
- •Patient with more than 3 ulcers.
- •Patient with ulcers measuring wound surface area more than 12 cm2 and depth more than 2cm
- •Patient having severe or poorly controlled Type II diabetes mellitus with severe hyperglycemia (RBG more than 250 mg/dL).
- •Patient having HbA1c of more than 12%.
- •Patient with severe ischemia with Ankle-Brachial Index (ABI) ≤ 0.
- •Patient having progressive weight loss.
- •Patient having poor nutritional status (S.
- •albumin less than 2.5g /dL).
- •Patient with ulcer deep into bone and joint or Osteomyelitis or Severe ulcer.
结局指标
主要结局
Percentage of subjects with complete healing of ulcer.
时间窗: 10 weeks
Complete healing’ will be defined as absence of visible wound by complete epithelialization.[Time Frame: 10 weeks ]
时间窗: 10 weeks
次要结局
- 1. Time taken for achieving complete wound closure from the baseline [Time Frame: 10 weeks ](2. Change in wound surface area from baseline [ Time Frame: 10 weeks ])