NCT04803708已完成1 期
A Double-Blind and Randomized Study to Determine the Safety and Tolerability of Multiple Doses of TP-102 in Subjects With Non-Infected and Infected Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- 3. Incidence and severity of treatment-emergent SAEs and relationship to IP from first administration until EOS.
研究概览
简要总结
This is a Phase I/IIa trial designed to evaluate topical bacteriophage therapy in patients with diabetic foot ulcers.
详细描述
The primary objective of this study is to evaluate the safety of a topical bacteriophage cocktail in the treatment of non infected and infected diabetic foot ulcers with Pseudomonas aeruginosa, Staphylococcus aureus and/or Acinetobacter baumanni. Patients will also be evaluated for bacterial clearance and wound reduction.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both cohorts:
- •Type 1 or type 2 diabetes mellitus with glycated hemoglobin (HbA1c) ≤10, 5%
- •Suitable physical and mental health as determined by the investigator based on medical history and general physical examination.
- •Subjects must be medically stable based on clinical laboratory tests, medical history and vital signs. Clinical laboratory tests should be within normal values or not clinically significant, unless directly related to the condition of diabetes.
- •Female subjects must fulfil one of the following criteria:
- •At least 1 year post-menopausal (amenorrhea >12 months prior to screening);
- •Surgically sterile (bilateral oophorectomy or hysterectomy);
- •If of childbearing potential, must agree to use a highly effective method of birth control from screening until 14 days after the last administration of IP.
- •Female subjects of childbearing potential must have a negative pregnancy test at screening.
- •Male subjects with a female partner of child-bearing potential or pregnant partner must agree to use a condom from screening until 14 days after the last IP application.
- •ICF signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of, and procedures required for the study and is willing to participate in the study.
- •Non-infected diabetic foot ulcer perfusion grade 1, depth grade 1 and infection grade 1 according to PEDIS classification.
- •Infected diabetic foot ulcer meeting perfusion grade 1 or 2, depth grade 1 or 2 and infection 2 or 3,except if presence of abscess, fasciitis, osteomyelitis, and septic arthritis, according to PEDIS definition.
- •Infected with at least one bacterial strain susceptible to bacteriophage cocktail assessed from culture.
排除标准
- •Both cohorts:
- •Study ulcer less than 2 cm away from other ulcers in case of multiple ulcers.
- •History in the 5 previous years of any cancer requiring systemic chemotherapy or radiation.
- •A condition that, in the opinion of the Investigator, could compromise the well being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements.
- •Immunocompromised subjects due to illness, organ transplant, or immune suppressive therapies (e.g. oral or parental corticosteroids, methotrexate, immune modulators) 3 months prior to screening. Ad hoc low dose inhaled corticosteroids or topical corticosteroids are not allowed from 2 weeks prior to randomization.
- •Being pregnant or breastfeeding.
- •Currently participating in another clinical trial or having participated in a previous clinical trial with receipt of an investigational product within 30 days of the first administration of IP or 5 half-lives, whichever is longer.
- •Subjects that, in the opinion of the Investigator or their treating physician, are dependent of the following therapies for their ulcer treatment:
- •Topical antimicrobial treatment (including isobetadine gel/dressing, silver nitrate dressing, topical antibiotic)
- •Enzymatic, autolytic, maggot debridement
- •Any active wound healing products (e.g., Dermagraft, Apligraf, Regranex, or Tegaderm hydrogel or others.)
- •Physical or cleansing modalities, antiseptics, corticosteroids, growth factors, solutions other than sterile normal saline and ulcer treatments.
- •Clinically infected ulcers
- •Suspected or confirmed abscess, fasciitis, osteomyelitis or septic arthritis.
- •Subjects meeting grade 3 or above PEDIS perfusion criteria
- •Planed or anticipated surgery after screening
结局指标
主要结局
3. Incidence and severity of treatment-emergent SAEs and relationship to IP from first administration until EOS.
时间窗: 1 week
1. Incidence and severity of treatment-emergent solicited local and systemic AEs and relationship to IP from first administration until 1 week after end of treatment (EOT) (end of study -EOS)
时间窗: 1 week
Local AEs include erythema/redness, swelling/induration, pain and tenderness Systemic AEs include fatigue, myalgia, fever, headache and gastrointestinal symptoms (nausea, vomiting, diarrhea)
2. Incidence and severity of treatment-emergent unsolicited AEs and relationship to IP from first administration until EOS.
时间窗: 1 week
次要结局
- Proportion of subjects with significant reduction or eradication from baseline in microbiologic data via culture (cfu) at d3, d8, d15, d22, d26 and EOS(35 days)
- Time (days) to significant reduction or eradication of target bacteria via culture.(35 days)
- Changes in wound/ulcer healing from to baseline in terms of wound size and depth (cm^3) at EOT.(35 days)
- Changes in wound/ulcer healing from to baseline in terms of wound complete closure and partial closure (25%, 50% and 75%) at EOT.(35 days)
研究者
研究点 (4)
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