Negative Pressure Wound Therapy as a Drug Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Compare clinical outcomes (time to wound healing, number of surgeries) with Negative Pressure Wound Therapy with irrigation and Negative Pressure Wound Therapy without irrigation.
研究概览
简要总结
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous irrigation and negative pressure wound therapy without irrigation.
The investigators will enroll 150 patients from two centers: The University of Texas Southwestern University Hospital and Parkland Hospital. The investigators will screen and enroll patients with wounds in the inpatient setting. Patients will randomized to receive traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average hospitalization for patents that receive NPWT is 13.3 days. Patients that do not have their wound surgically closed during hospitalization will be discharged with negative pressure wound therapy without irrigation for up to a total of four weeks of therapy. After discharge from the hospital, subjects will be seen twice weekly by home health, and the investigators will evaluate subjects in clinic every 7 days (±7 days) for a total of 16-week period or until the wound heals.
详细描述
Screening Procedures
- Review and sign the Informed Consent and HIPAA Authorization
- The study doctor will review the inclusion and exclusion criteria
- Demographics (such as age, gender, race or ethnicity)
- Sitting blood pressure and pulse at admission
- Collection of Height and weight at admission
- Collection of the medical and surgical history
- Collection of the history of the wound
- Wound assessment(s) - wound etiology, wound history, location of study wound and infection assessment
- Hyperspectral imaging within 30 days of screening
- Vascular/Neurological evaluation - we will do various tests and measurements to assess the sensation (feeling) and circulation (blood flow) in the subject's feet and lower legs. To assess the sensation, we will do a monofilament sensory test and a vibration threshold perception test on the study foot. We will calculate the neuropathy disability score of both feet. To assess circulation, we will record Skin Perfusion Pressures in the study foot using a Sensilase System (Vasamed, Eden Prairie, MN) within 30 days of screening. We will calculate the ankle brachial index (ABI) at screening and collect available arterial doppler data from the medical record within 6 months of screening. None of these tests are invasive (using needles), uncomfortable or have risks greater than standard care.
- Results of standard-of-care laboratory tests including a white blood cell count, blood chemistry (tests to see how well organs, such as the liver and kidneys are working), glycated hemoglobin, albumin, prealbumin, erythrocyte sedimentation rate, C-reactive protein and blood glucose. Results of a serum pregnancy test (standard care for women of child-bearing potential as part of pre-op labs) will also be collected. Collection of a list of the subject's current antibiotics
- We will provide the SF-36 Questionnaire and other patient-reported outcomes questionnaires and collect them while subjects are inpatient.
This visit will last about 2 hours.
If you qualify for the study, you will participate in the following procedures:
Group Assignment
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
- None
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus
- •Men/women ≥21 years old
- •Foot or ankle wounds sized 5 cm2 -100 cm2
- •ABI≥0.5 or toe pressures >30 mmHg
排除标准
- •Active Charcot arthropathy
- •Unable to use NPWT at home
- •Untreated bone or soft tissue infection
- •Unable to keep research appointments
- •Active alcohol or substance abuse (> 14 drinks per week over the last 3 months) or substance abuse (current use of cocaine, heroine or methamphetamine or if drug or alcohol use will interfere with follow up visits in foot clinic in the opinion of the investigator)
研究组 & 干预措施
Quantum™ Therapy/NPWT with Prontosan
Quantum™ Negative Pressure Wound Therapy with Prontosan irrigant.
干预措施: Quantum™ Therapy - NPWT with Prontosan (Device)
Quantum™ Therapy
Quantum™ Negative Pressure Wound Therapy without irrigant.
干预措施: Quantum™ Therapy (Device)
结局指标
主要结局
Compare clinical outcomes (time to wound healing, number of surgeries) with Negative Pressure Wound Therapy with irrigation and Negative Pressure Wound Therapy without irrigation.
时间窗: Up to 12 weeks
The investigators expect that patients treated with NPWT with irrigation will a have higher proportions of wounds that heal, fewer surgeries, and faster wound healing trajectories when compared to patients treated with traditional NPWT without irrigation.
次要结局
- Compare quantitative cultures (bacterial load as measured by qPCR) and number of clinical infections in patients treated with NPWT with irrigation compared to conventional NPWT.(Up to 12 weeks)