A Pilot Randomized Trial of Flexitouch as an Adjunctive Treatment for Venous Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Wound Healing
研究概览
简要总结
This is a study to compare the healing process of venous stasis ulcers when the Flexitouch® system is added to the standard treatment of venous ulcers. We hypothesize that adding the Flexitouch® system to standard venous ulcer treatment will result in
- greater complete healing
- greater percentage reduction in ulcer area
- reduced time to complete healing, as compared to the use of standard treatment alone
- a greater reduction in affected leg volume as compared to standard treatment alone.
详细描述
A pilot randomized trial of Flexitouch® as an adjunctive treatment for venous ulcers
Objectives To determine if the Flexitouch® compression therapy system, when added to standard venous ulcer (VU) treatment, results in: 1. Greater complete healing at 12 weeks as compared to standard treatment alone. 2. Greater percentage reduction in ulcer area at 12 weeks as compared to standard treatment alone. 3. Less time to complete healing as compared to standard treatment alone 4. A greater reduction in the leg volume of the affected leg
Hypothesis We hypothesize that adding the Flexitouch® system to standard venous ulcer treatment will result in
- greater complete healing, 2) greater percentage reduction in ulcer area 3) reduced time to complete healing, as compared to the use of standard treatment alone, and 4) a greater reduction in affected leg volume as compared to standard treatment alone.
Patient recruitment, eligibility, and exclusions Patients who present at our clinic with a venous leg ulcer, as judged by clinical presentation and history, will be recruited for participation in this research study. For this pilot study a total of 16 patients will be recruited.
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
- •Patient must be at least 18 years old
- •The ulcer maximum length x its maximum width must be greater or equal to 0 cm2
- •The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone.
- •The ulcer must have been present for more than 1 month.
- •The ulcer must be located below the knee.
- •The ulcer bed must have some viable tissues with some granulation tissue.
排除标准
- •Exposed bone, tendon, or fascia
- •Severe rheumatoid arthritis
- •History of radiotherapy to the ulcer site
- •Uncontrolled congestive heart failure
- •Receiving corticosteroids or immune suppressive therapy
- •History of collagen vascular disease
- •Known malnutrition (albumin<3.0 g/dL). If malnutrition is suspected, the albumin level should be checked to determine if the patient meets the albumin criterion.
- •The ulcer is clinically infected. However, patients may be entered into the study after successful treatment of infection.
- •Known uncontrolled diabetes (HgbA1c > 8%). If uncontrolled diabetes is suspected, the Hgb A1c should be checked to determine patient eligibility.
- •Signs of cellulitis, osteomyelitis, or necrotic or avascular ulcer bed(s).
- •Known arterial insufficiency (Ankle-brachial index < 0.7, or TcPO2 < 35 mm Hg, or Toe-brachial index < 0.4). If peripheral vascular disease is suspected, vascular lab testing should be checked to determine patient eligibility.
- •Active sickle cell disease
- •Unable to comply with the procedures described in the protocol
- •Enrolled in a clinical evaluation for another investigational wound-care device or drug
- •Patients diagnosed with deep venous thrombosis or phlebitis in the affected limb in the last 6 months
- •Pregnancy, suspected or confirmed
- •Chronic renal disease, if deemed by the principal investigator to be severe enough to interfere with wound healing
- •Known active or recurrent cancer, or currently receiving chemotherapy or radiation therapy
- •History or pulmonary embolism
- •Poorly controlled asthma
- •Pulmonary Edema
研究组 & 干预措施
Standard Wound Care
Gentle wound ulcer cleansing with saline solution at each visit, maintaining moisture balance in the wound and periwound with appropriate dressings (e.g Acticoat, Aquacel Ag, or Mepilex Ag foam dressings), reminding subjects of importance of proper nutrition, leg elevation at rest and activity, including frequent ambulation and ankle range of motion exercises through the day. The FarrowWrap Classic device is applied over the dressing to achieve suitable compression pressures as an important component of the standard treatment.
干预措施: Standard Wound Care (Device)
Flexitouch system with Standard Wound Care
In addition to standard wound care, patients who have been randomized to this group will be provided a home Flexitouch unit. They will be given instructions to use it on a twice daily basis (FarrowWrap will be removed during the time they are using Flexitouch). The Flexitouch System works by applying dynamic low-pressure compression to the trunk and affected limbs using gentle, rhythmic massage action.
干预措施: Flexitouch System with Standard Wound Care (Device)
结局指标
主要结局
Wound Healing
时间窗: 12 weeks
次要结局
- Reduction in Leg Volume(12 weeks)