Healing Rate of Chronic and Sub-Acute Lower Extremity Ulcers Treated With Contact Ultrasound Followed by MIST Therapy: The VIP Ultrasound Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Total Wound Area
研究概览
简要总结
Wound healing rate is higher when contact ultrasound therapy is followed by noncontact ultrasound therapy on sub-acute and chronic lower extremity ulcers of various etiologies requiring selective debridement, as compared to either Sonoca-180 or MIST Therapy alone.
详细描述
This prospective pilot study is designed to evaluate the clinical effectiveness of a wound care ultrasound treatment protocol for sub-acute or chronic wounds of the lower extremity and of any etiology. The Viana-Pompeo (VIP) ultrasound protocol consists of high intensity, low frequency, contact ultrasound therapy (with Sonoca-180) followed by low intensity, low-frequency, noncontact ultrasound therapy (with MIST Therapy). Previously published healing rates for each of the ultrasonic therapy modalities will be used as a comparison.
The Physical Therapist will perform the initial assessment and treatment, and devise an individualized plan of care that involves contact ultrasound followed by noncontact ultrasound. Subjects may remain in the study for up to 12 weeks, or up to when end of study criteria is met.
Transition from contact mode to noncontact mode will happen when:
- Wound is sufficiently clean with ≤ 20% of necrotic tissue or adherent slough.
OR
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
- •Patient is referred to Physical Therapy for contact ultrasound (which is included in the VIP protocol);
- •Lower extremity (including foot) wound(s) of any etiology;
- •Wound(s) presenting with slough, necrotic tissue, and/or non-viable tissue requiring debridement;
- •Wound is present for 4 weeks or longer at the start of ultrasonic therapy;
- •Insurance approval is obtained for Contact and Noncontact ultrasound treatments, in the ambulatory setting;
- •Patient is 18 years of age or older;
- •Female patient attesting not to be pregnant;
- •Not undergoing Vacuum Assisted Closure (VAC) therapy.
排除标准
- •Patient is referred to Physical Therapy for noncontact ultrasound only;
- •Wound(s) not on lower extremity;
- •Clean wound(s) that do not require debridement;
- •Wound onset less than 4 weeks prior to the start of ultrasonic therapy;
- •Malignancies on the treatment area;
- •Patients in the ambulatory setting whose insurance did not approve them for both contact and noncontact ultrasound therapy;
- •Patient is under 18 years of age;
- •Female patient attesting to be pregnant;
- •VAC Therapy.
结局指标
主要结局
Total Wound Area
时间窗: Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
Mean and Standard Deviation of the group's total wound area at day one and last treatment day. Wound area was measured as Length x Width. This is to assess the change in area, in order to assess wound progress towards closure.
次要结局
- Total Wound Volume(Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.)
- Wounds With Slough/Eschar Reduction on Visit 2 and Wounds With Slough/Eschar Reduction at Last Visit(Day 2 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.)
研究者
Lisley Viana
Physical Therapist
Texas Health Resources