Study to Evaluate Bacterial Activity That Drives the Progression of Clinical Infection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Assess serum IgG titers
研究概览
简要总结
The investigators plan to enroll up to 750 subjects over the course of 5 years. Study duration will be 2 visits over 7 days (+/-3). Participants will be consented and undergo baseline procedures. Participants will be grouped into 1 of 3 groups, based on infection and antibiotic status at screening. Debridement will be performed per standard of care and collection of tissue will be taken from this discarded tissue. A blood draw will be performed at each of these two visits as well. This is for research purposes only. All other data will be obtained from the electronic medical record. All standard of care except for the blood draws.
详细描述
Study Groups:
Participants will be divided 1:1:1 into groups with
- Cohort 1: clinically uninfected (1A and 1C) ulcers.
- Cohort 2: clinically infected (redness, edema, induration, heat, exudate, tenderness/pain (1B and 1D)) with no recent antibiotic therapy (within 28 days)
- Cohort 3: clinically infected (redness, edema, induration, heat, exudate, tenderness/pain (1B and 1D)) on antibiotic therapy
Duration of Subject Participation
- Screening: Within 7 days of baseline visit
- Baseline (can be the same day)
- Week 1 visit: one week after baseline.
- Follow-up period - EMR: 6 months from baseline measurements
- Total duration of subject participation: Up to 6 months
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ankle Brachial Index (ABI) ≥ 0.5 (bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery)
- •One or more chronic lower extremity wounds that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit, however, only one wound per subject will be included.
- •Ulcer grade I or II, Stage A-D, according to University of Texas Wound Classification System
- •≥21 years of age or older
- •Diagnosis of diabetes mellitus
排除标准
- •• Subject has major immunodeficiency
- •Subject is human immunodeficiency virus (HIV)+
- •Subject has untreated osteomyelitis
- •Subject has active cellulitis
- •Subject has active charcot
- •Is pregnant or plans to become pregnant
- •Is nursing or actively lactating
- •Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years
- •Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
结局指标
主要结局
Assess serum IgG titers
时间窗: Five years
Assess serum IgG titers against our target antigens and host gene expression analysis
次要结局
- Characterize microbiology(Five years)