Evaluation of Micro Water Jet Technology and the Progression of Wound Healing: A Prospective Cohort Evaluating the Efficacy of Micro Water Jet Technology in the Debridement and Healing of Chronic Lower Extremity Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Size of Ulcers
研究概览
简要总结
This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.
详细描述
This is a prospective cohort, single-center, open-label study in subjects with chronic lower extremity wounds. The study will enroll up to 20 subjects. Subjects will undergo screening evaluations to determine eligibility to enroll in the study. All study subjects will receive micro water jet technology debridement as opposed to other debridement methods as part of their wound care treatment. The other aspects of subjects wound care protocol will remain unchanged. In the case of bilateral limb ulcers, or multiple ulcers, subjects will have the option to receive micro water jet debridement on one or all of the ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female age 18 or older
- •The ability and willingness to provide Informed consent
- •Presence of a chronic lower extremity ulcer
- •Chronic ulcer is defined as that greater than 4 weeks in duration.
- •Subject's informed consent for participation prior to proceeding with micro water jet technology debridement
- •Patient's ulcer cannot exhibit any gross clinical signs of infection.
- •Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- •Patient willing and able to comply with having micro water jet technology debridement potentially weekly or biweekly as part of their wound care treatment plan for up to 20 weeks.
排除标准
- •Patients with active wound infection, or untreated osteomyelitis
- •Patients with dementia, or impaired cognitive function
- •Patients who are unable or unwilling to participate in all procedures and follow up evaluations
- •Patient has Active Charcot foot
- •Patient with malignant wounds
结局指标
主要结局
Size of Ulcers
时间窗: Up to 20 weeks or when the ulcer is healed, whichever is sooner.
The extent and size of ulcers (summation of the products of the long x short axis for all ulcers measured in centimeters squared, plus ulcer depth) will be evaluated and photographs of ulcers taken during screening and on all clinic visits up to 20 weeks or when the ulcer is healed, whichever is sooner.
Leg Rest Pain Score
时间窗: up to 20 weeks, or when the ulcer is healed, whichever is sooner
Leg rest pain score - visual analogue scale (VAS) graded from 0 (pain free) to Grade 10 (maximum pain) during screening and on all clinic visits up to 20 weeks, or when the ulcer is healed, whichever is sooner.
Subjects Feedback
时间窗: At end of their study participation
Subjects feedback regarding their debridement experience with micro water jet technology will be collected on all clinical visits when debridement is performed.
Pain During Debridement Score
时间窗: up to 20 weeks, sooner pending wound healing.
Pain during Debridement score - VAS graded from 0 (pain free) to Grade 10 (maximum pain) during on all clinical visits when debridement is performed for up to 20 weeks, sooner pending wound healing.
次要结局
未报告次要终点
研究者
Stephanie Wu
Principal Investigator
Rosalind Franklin University of Medicine and Science