Electrical Stimulation as an Adjunctive Therapy to Accelerate Wound Healing in People With Diabetic Foot Ulcers - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in Skin Perfusion in Response to Electrical Stimulation Therapy
研究概览
简要总结
A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and Endovascular Therapy, is being proposed to test the efficacy of a novel electrical stimulation platform named the Tennant Biomodulator designed by AVAZZIA to accelerate wound healing, relieve pain and improve mobility in patients with diabetic foot ulcers.
详细描述
Electrical stimulation may offer a unique treatment option to heal complicated and recalcitrant wounds, improve flap and graft survival, and even reduce the likelihood of ulceration. Electrical stimulation has been suggested to reduce infection, improve cellular immunity, increase perfusion, relieve pain, improve plantar sensation, and accelerate wound healing.
Electrical stimulation could have positive effect on not only increasing skin perfusion in patients with diabetes but also could improve mobility and balance via enhancing plantar sensation as demonstrated in our recent study. Thus, plantar stimulation not only may be beneficial to accelerate wound healing in diabetic foot ulcer (DFU) patients but also may assist to improve mobility and reduce the likelihood of recurrence of ulcers.
This study is proposed to examine the effectiveness of an innovative portable electrical stimulation platform (Tennant Biomodulator by AVAZZIA) to accelerate wound healing in DFU patients. It is hypothesized that 1) electrical stimulation will have an immediate effect on increasing skin perfusion (immediate benefit) and 2) daily use of the Tennant Biomodulator for 4 consecutive weeks is effective to speed up wound healing, increase skin perfusion, reduce pain, and improve balance and mobility in DFU patients (long term benefit)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Devices may be active or sham.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •18-85 years old
- •Clinically confirmed diabetes (ADA criteria)
- •Clinically confirmed Peripheral Neuropathy
- •One or more active non-infected ulcers
- •Subject or responsible caregiver is willing and to maintain the required offloading (as applicable the location of the ulcer) and applicable dressing changes and electrical stimulation application.
排除标准
- •Subject has a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device
- •Is pregnant
- •Is nursing or actively lactating
- •Has Renal Disease
- •Active wound infection
- •Active Charcot foot
- •Non-ambulatory (unable to walk 40 feet with or without assistive device)
- •Bilateral AK/BK amputation
- •Active drug/alcohol abuse
- •Dementia or impaired cognitive function
- •Excessive lymphedema
- •Osteomyelitis and/or gangrene
- •Unable to comply with research appointments (e.g. long travel) Wide spread malignancy or systemically imumno-compromising disease
- •Subject has a history of or any intercurrent illnesses or conditions that would compromise the safety of the subject according to judgement of a qualified wound specialist.
结局指标
主要结局
Change in Skin Perfusion in Response to Electrical Stimulation Therapy
时间窗: Change at 4 weeks from baseline.
Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.
Change in Wound Size in Response to Electrical Stimulation Therapy
时间窗: Change at 4 weeks from baseline
Wound size will be assessed with a Sillouette Star 3D Camera that detects width, length, and depth of wounds that automatically gives you a cm2 area.
次要结局
- Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation(Change at 60 minutes from baseline.)
- Change in Tissue Oxygen Saturation in Response to Electrical Stimulation(Change at 4 weeks from baseline.)
- Change in Plantar Sensation in Response to Electrical Stimulation(Change at 4 weeks from baseline.)
研究者
Bijan Najafi, PhD
Professor of Surgery
Baylor College of Medicine