Toward Smart Personalized Electrotherapy for Enhanced Healing of Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Digital imaging
研究概览
简要总结
Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds.
Research Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use.
Methodology: All participants with chronic ischemic wounds treated at Louis Stokes Cleveland VA Medical Center (LSCDVAMC) will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1) Age less than 18 years and (2) Pregnancy.
Clinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.
详细描述
The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of the exciflex bandage in clinical use. Non-invasive assessments will include multi-modal imaging using the Mimosa Pro imaging system, MolecuLight and wound swabs to collect wound bed fluid thus meeting the recommendations of Ramsay et al. for obtaining accurate, reliable standardized samples. Wound healing primary endpoints will follow Wound Care Collaborative Community guidance. The study cohort will comprise Veterans with chronic wounds.
A parallel-group randomization will be used and participants will be randomly assigned to one of two groups: the experimental or investigation group (Group A) or the control group (Group B). Random allocation software will be used to produce qualified lists for parallel group assignment a priori and ensure that participants are randomized into groups that result in equal sample sizes Each will have a 50% chance of being assigned to either group. The two groups are Group A (exciflex treatment and monitoring) or Group B (sham treatment, i.e. exciflex monitoring without treatment activated)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants with chronic wounds treated at LSCVAMC will be potentially eligible for the study
- •Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long-Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care
排除标准
- •In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include:
- •Pregnancy
研究组 & 干预措施
Group B: Wound treated using standard of care
Control treated wounds in Group B participants will be covered with an exciflex bandage that is not activated . The bandage will be used for up to 10 weeks or until the wound is healed for 3 days. The bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically multi-modal digital imaging and wound swabs . A fresh sterile inactive exciflex bandage will then be reapplied to the wound.
Group A: Wound treated using exciflex
Intervention treated wounds in Group A participants will be covered using the exciflex bandage which will be activated to deliver ES using a 10% duty cycle, i.e. ES will be active for 1 minute out of every 10 minutes. ES will be delivered for up to 10 weeks or until the wound is healed for 3 days. The exciflex bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically multi-modal digital imaging and wound swabs. The exciflex power/control module will then be transferred to a new sterile flexible substrate and the exciflex bandage reapplied to the wound.
干预措施: exciflex (Device)
结局指标
主要结局
Digital imaging
时间窗: At each bandage change for up to 6 weeks
Quantify wound size (mm2 for surface area, mmm3 for volume). The outcomes measures of wound surface area \& wound volume are done by the investigators' 3D wound imaging camera that produces a digital output which includes both wound surface area (SA) \& wound volume. One is derived from the other, i.e. Wound volume = SA x average depth.
IR imaging
时间窗: At each bandage change for up to 6 weeks
Wound bed temperature (degrees C)
Laser Speckle imaging
时间窗: At each bandage change for up to 6 weeks
Wound region blood flow (blood perfusion using arbitrary units)
次要结局
- Wound swabs(At every bandage change for up to 6 weeks)