The Role of the Microbiome in Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- The percent change in foot ulcer surface area square centimeter (cm2) after 12 weeks of observation for infected diabetic foot ulcers
研究概览
简要总结
The purpose of this study is to evaluate the role of rapid diagnosis of pathogens in treatment of infection and wound healing in diabetic foot ulcers. This research is studying the use of a new device of people to learn if metagenomic next generation sequencing (mNGS) techniques technology is a feasible tool that can be used to direct targeted antibiotic therapy in infected diabetic foot ulcers.
Participant's tissue will be randomized to usual care tissue collection and cultures (standard of care) or usual care tissue collection and cultures (standard of care) plus metagenomics next generation sequencing (mNGS). The participant's will not be randomized to any treatment (i.e. antibiotic therapy).
详细描述
Participants will have tissue taken per standard of care at the baseline visit. In addition, participants will complete of a comprehensive medical history questionnaire, Michigan Neuropathy questionnaires, and have assessments of the foot ulcer or wound. The study team will follow participants for approximately 12 weeks.
Initial antibiotic therapy to treat diabetic foot ulcer infections are determined by participants treating provider and are based on clinical characteristics, drug allergies or sensitivities, and suspected causative pathogen (i.e., bacteria). In this study, the identification of pathogens using mNGS will be given to the treating physician and may result in additional or different antibiotics.
The decision for antibiotic prescription(s) to treat the diabetic foot ulcer infection will be made by treating providers. The antibiotic plan will be updated according to final culture results (usually 4-6 days following culture of tissue). For those participants randomized to the mNGS cohort, the results (usually 24-36 hours following culture of tissue) will be shared with the treating physician. The treating physician may provide additional or different treatment than initially prescribed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (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
- •Patients with diabetes mellitus
- •Have an infected DFU with a surface area ≥0.5 square centimeter (cm2)
- •o DFU Infection status will be clinically recorded at time of enrollment according to Infectious Disease Society of America (IDSA): mild, moderate, or severe infection
- •Have a hemoglobin A1c[HbA1c] of 12% or less as measured within the last 6 months,
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Pregnant or lactating
- •Uncontrolled blood glucose as demonstrated by a HbA1c of greater than 12%
- •Bilateral wound or ulcer
- •Current infection of Coronavirus disease 2019 (COVID19)
- •Unable to provide informed consent or are unwilling to participate
研究组 & 干预措施
Conventional bacterial culture
Wound tissue removed will be sent for standard of care evaluation.
干预措施: Conventional bacterial culture (Diagnostic Test)
Conventional bacterial culture plus rapid diagnostic group
Wound tissue removed will be sent for standard of care evaluation as well as rapid diagnostic with metagenomics next generation sequencing (mNGS).
干预措施: Conventional bacterial culture (Diagnostic Test)
Conventional bacterial culture plus rapid diagnostic group
Wound tissue removed will be sent for standard of care evaluation as well as rapid diagnostic with metagenomics next generation sequencing (mNGS).
干预措施: Rapid diagnostic group using mNGS technology (Device)
结局指标
主要结局
The percent change in foot ulcer surface area square centimeter (cm2) after 12 weeks of observation for infected diabetic foot ulcers
时间窗: Baseline, 12 weeks
次要结局
- Total days of antibiotic therapy for the infected DFU participants(Baseline up to 12 weeks)
- Number of days to infection resolution for the infected DFU participants(Baseline up to 12 weeks)
- Proportion of participants that reach a 50% reduction in surface area (cm2) of the infected DFU(Baseline up to 12 weeks)
- The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4(Baseline to 4 weeks)
- The percentage of participants with an infected DFU at baseline that are hospitalized for infection during the study.(Baseline up to 12 weeks)
- Post study percentage change of wound surface area (cm2).(Baseline up to 12 weeks)
- Percent of clinical resolved infected DFU for infected DFU participants with clinically resolved infection defined as improvement of greater or equal to two clinical signs of infection(Baseline up to 12 weeks)
- The percentage of participants with an infected DFU at baseline that undergo a non-traumatic lower extremity amputation during the study.(Baseline up to 12 weeks)
研究者
Brian Schmidt
Associate Professor of Internal Medicine
University of Michigan