A Randomized Controlled Trial to Investigate if Application of Low Frequency Ultrasound-assisted Debridement May Improve Healing and Infection Outcomes for the Person With Vasculopathy and Recalcitrant Wounds of the Lower Extremity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in wound surface area
研究概览
简要总结
The UltraHeal Study is a randomized controlled trial to compare healing response of low frequency contact ultrasonic-assisted debridement in addition to best practice wound care to best practice wound care alone in a Vascular Surgery Clinic patient population with wounds of the lower extremity.
详细描述
The study will also investigate the bacterial tissue burden and protease activity to provide further insight into the infection and inflammation aspects of healing barriers in a challenging population.
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
- 是
入选标准
- •Persons with lower extremity wound referred to vascular surgery service.
- •Full thickness wound below the knee with surface area of at least 1cm
- •Age >18 years
- •English speaking
- •Ulcer of known etiology including diabetic foot wounds, and arterial or venous leg ulcers
- •Willing and able to adhere to 12 week study protocol that includes attending weekly clinic appointments, and wearing prescribed footwear or compression therapy
排除标准
- •Leg wounds due to inflammatory conditions (e.g. pyoderma gangrenosum, vasculitis), malignancy, or other unknown etiologies.
- •Severe arterial insufficiency: Absence of pedal pulses combined with Ankle Brachial Index ≤ 0.3, Toe Pressure ≤20, or Trans Cutaneous Oxygen Measure ≤20
- •Presence of acute limb threatening infection
- •Vascular surgery planned within next 3 months
- •Exposed vascular graft or blood vessel, bone or tendon in the base of the wound.
- •Currently receiving advanced wound therapy treatments: Hyperbaric therapy, biological dressings [collagen or extracellular matrix dressings].
- •Increased likelihood of an adverse reaction to ultrasonic debridement due to:
- •Excessive wound pain (>5 VAS scale) or patient described intolerable
- •Allergy to topical anesthetic (lidocaine)
- •Individuals who have factors/circumstances that are known to limit their ability to demonstrate healing in 4 weeks.
- •For example:
- •medically unstable or palliative medical status
- •poor nutritional status (low serum albumin < 15),
- •anemia (Hb < 75 mg/dl),
- •taking immunosuppressant medication (prednisone, chemotherapy; transplant anti-rejection medication),
- •Individuals with medical conditions that contraindicate the use of ultrasound energy
- •Cardiac pacemaker or defibrillator
- •Excessive bleeding tendency (> 5 mins post debridement) or identified coagulopathic disorders
- •Exposed bone in the wound base
- •Untreated osteomyelitis
研究组 & 干预措施
Ultrasound debridement
Participants receiving ultrasound assisted debridement in addition to best practice wound care.
干预措施: Ultrasound debridement (Device)
Best Practice wound care
Participants receiving best practice wound care alone
干预措施: Best practice wound care (Device)
结局指标
主要结局
Change in wound surface area
时间窗: Weekly for 4 weeks then at 12 weeks.
The wound surface area will be measured weekly once treatment is initiated, with a final measurement 12 weeks after initiation of therapy.
次要结局
- Protease activity(Pre-treatment, post treatment at weeks 5 and weeks then at 12 weeks.)
- Bacterial burden(Pre-treatment, week 5 and week 12)
- Number of wounds healed(Throughout duration of the study)