Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Bacterial Quantification Over Time
研究概览
简要总结
The key purpose of this study is to determine and understand the safety and effectiveness of blue light phototherapy in the treatment and healing of infected diabetic wounds, as well as determining if this treatment is capable of reducing the bacterial population number within infected wounds. The investigators' lab recently discovered that a specific survival protein called catalase can be destroyed through blue light exposure. Given that a majority of bacteria species contains catalase, it is hypothesized that the destruction of this protein can improve the effectiveness of antimicrobial wound dressings commonly used to treat infected diabetic wounds, therefore further reducing the amount of bacteria within the wound and increasing the rate of healing. By reducing the overall bacterial population within these diabetic infected wounds, the ability for these diabetic wounds to heal will be enhanced, allowing for greater reductions in wound size over the course of the treatment.
In this study, 40 subjects will be enrolled and randomly assigning subjects to either a control group or a phototherapy receiving experimental group. While control subjects will receive standard weekly debridement treatment procedures for infected diabetic ulcers, experimental subjects will receive standard weekly debridement treatment alongside 2 sessions of phototherapy every week over the course of 12 weeks. Bacterial swab samples will be taken alongside the excised debrided infect tissue for the purpose of bacterial population analysis. For each patient, the changes in total bacterial population, wound size, and subject satisfaction will be recorded and analyzed to determine the effectiveness of pulsed light phototherapy.
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
- 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
- •English Speaking
- •Capacity to Consent
- •Diabetic Foot Ulcers
- •Have an infected wound present on the foot greater than 1 (one) cm2 and less than 8 cm2
- •Ability to utilize appropriate offloading devices as recommended by a clinician
排除标准
- •Pregnant or breastfeeding/nursing
- •Ankle-brachial pressure index below 0.45 or over 1.4
- •Hemoglobin A1c levels above 12.0
- •Stage 4 renal disease/dialysis
- •Taking immunosuppressant medications
- •Undergoing radiation therapy
- •Diagnosed Uncontrolled/Resistant hypertension (HTN) - High blood pressure that does not respond well to medical treatment, blood pressure remains above average (usually 130/80 mmHg) despite medication usage.
- •Diagnosed Uncontrolled malabsorption disorder - Small intestine unable to absorb nutrients effectively, usage of nutrient supplements ineffective
- •Active sepsis
- •Uncontrolled coagulopathy - Blood unable to properly coagulate and form clots, low platelet or clotting factor levels, unresponsive to medications
- •Untreated bone/soft tissue infection - Not yet initially treated to reduce risk of sepsis
- •Gangrene of wound under care
结局指标
主要结局
Bacterial Quantification Over Time
时间窗: 12 weeks
Bacterial swabs will be collected from each subject's wound before and after weekly debridement. These weekly bacterial swabs, in addition to the homogenized debrided tissue, will be used to assess a patient's overall bacterial burden and bacterial population. Overall bacterial counts and population within each sample will be determined through the use of colony-forming unit (CFU) counting on agar plates or bacterial sequencing.
次要结局
- Wound Size Reduction Over Time(12 weeks)
- Subject Phototherapy Treatment Satisfaction: questionnaire(12 weeks)