A Randomized Trial of the Flexitouch Compression System as an Adjunctive Treatment for Venous Stasis Ulcer
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 4
- 主要终点
- Complete Healing Rate of Venous Stasis Ulcers
研究概览
简要总结
The researchers hypothesize that utilization of the Flexitouch system will improve the healing rates of (venous stasis ulcers) VSU compared to traditional compression wrapping therapy alone.
Primary Objective: The primary study objective is to determine whether the complete healing rate of venous stasis ulcers at 12 weeks is improved by the addition of Flexitouch® System compression therapy to a standard regimen of compression wrapping.
Secondary Objectives:
- To determine whether the addition of Flexitouch System compression therapy to a standard regimen of compression wrapping increases the percentage reduction in wound surface area.
- To determine whether the addition of Flexitouch compression therapy to a standard regimen of compression wrapping increases the percentage reduction in volume of the affected limb.
- To determine whether the addition of Flexitouch compression therapy to a standard regimen of compression wrapping decreases the time to healing of the venous stasis ulcer.
详细描述
Background:
Overview of venous stasis ulcers (1-3): Venous stasis ulceration is a common complication of venous insufficiency in the United States. Venous stasis ulcers (VSU) are associated with very significant morbidity, including patient disability, moderate to severe pain, and frequent leg infections. There is also a large cost associated with the medical care needed for this condition and the inability of patients to work. In some patients, this condition can be life- or limb-threatening.
Current standard of care for VSU: It is widely accepted that VSU should be treated by an individualized program of compression wrapping therapy (3-5). This therapy is designed to counteract the presumed pathophysiology of VSU, which develop as a result of valvular reflux and venous hypertension. However, the efficacy of compression therapy alone is suboptimal, with healing rates of roughly 34% reported after 12 weeks of therapy (6). Various adjunctive treatments have been studied, including artificial skin grafts (6-8). However, none of these adjunctive modalities have become widely accepted for the treatment of VSU.
Potential role of compression pumps: Intermittent sequential compression pumps are widely used as an adjunctive modality in the treatment of VSU. These pumps use high compression and are expensive, but this expense may be outweighed by improved healing of VSU. The use of compression pumps is consistent with the pathophysiology of VSU, but data regarding the efficacy of such therapy is scarce. To date, no study has adequately assessed the efficacy of compression pump therapy in the treatment of VSU (9).
Flexitouch System: The Flexitouch System was designed by a therapist trained in manual lymphatic drainage therapy and is produced by Tactile Systems Technology, Inc. The Flexitouch System was designed to simulate MLD techniques and is intended for home use during the self-management phase of CDT. MLD is one (of four) component(s) of Complete Decongestive Therapy, considered the "Gold Standard" for treatment of lymphedema. MLD is a gentle, manual technique producing very light directional pressure/stretch on the skin with manipulation of healthy lymph nodes and vessels. The effects of properly applied MLD include increased intake of lymphatic loads into the lymphatic system, increased lymphangiomotoricity, increased volume of transported lymph fluid, increased venous return in the superficial venous system, promotion of parasympathetic response and pain control. Treatment is always initiated at the trunk segments, with decongestion of proximal areas, prior to addressing the involved extremity (to clear central areas and promote decongestion of more distal areas). The extremity is then treated in segments, starting with the proximal segments and then progressing from distal to proximal regions. The Flexitouch® System is not intended to replace the intensive phase of CDT. However, it follows the principles of MLD in many ways. Flexitouch system provides limb treatment, but in addition, it addresses trunk congestion. The lower extremity garment set consists of two garments, one garment fits over the affected lower extremity and the other fits over the lower abdomen/trunk. Each garment is made up of multiple inflatable chambers within a flexible, stretchable fabric. The treatment consists of a 2-phase program. As in MLD, the preparation phase begins the treatment starting at the inguinal quadrant. Each curved trunk chamber inflates and deflates sequentially to facilitate the movement of edema fluid into the systemic circulation. The cycle is repeated several times. The inflation/deflation cycle is then repeated in each limb region from the knee to the groin, from the ankle to the knee, and finally from the toes to the ankle. The second phase, drainage, begins the sequential inflation/deflation cycle at the toes and continues moving up the leg to the quadrant of the trunk to facilitate the movement of edema fluid from the inguinal quadrant into the system circulation.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will enroll patients in a prospective manner with chronic venous insufficiency and venous stasis ulceration as determined from clinical presentation, positive venous reflux testing, or both.
- •Patients must be 18 years old or more.
- •The VSU size must be in the range 1-64 cm
- •The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone.
- •The VSU must have been present for more than 1 month.
- •The ulcer must be located between and including the knee and ankle.
- •The wound bed must have viable tissues with 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 suppressives.
- •History of collagen vascular disease.
- •Known malnutrition (albumin < 2.5 g/dL). If malnutrition is suspected by the principal investigator, the albumin level should be checked to determine whether the patient meets the albumin criterion.
- •Ulcer clinically infected at the time of entry into the study. However, patients may be entered into the study after successful treatment of infection.
- •Known uncontrolled diabetes (HgbA1c > 12%). If the principal investigator suspects uncontrolled diabetes, 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 mmHg, or Toe brachial index < 0.4). If the principal investigator suspects uncontrolled diabetes, the Ankle-brachial index 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.
- •History of peripheral vascular disease, or chronic renal disease.
- •Known active or recurrent cancer, or currently receiving chemotherapy or radiation therapy.
- •History of pulmonary embolism.
- •Poorly controlled asthma.
- •Use of Apligraf, skin graft or similar biological dressing within 30 days of study entry.
- •Patients with concurrent atrophie blanche.
结局指标
主要结局
Complete Healing Rate of Venous Stasis Ulcers
时间窗: 12 weeks
Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.
次要结局
- Change in Wound Surface Area for Non Healed Subject at 12 Weeks.(12 weeks)
- Percentage Change in Volume of the Affected Limb (-Reduction; +Increase)(12 weeks)
- Time to Healing of the Venous Stasis Ulcer(Baseline to 12 weeks)
研究者
Satish Muluk
Professor, Surgery, Temple University School of Medicine; Associate Professor, Cardiothoracic Surgery, Drexel University College of Medicine
West Penn Allegheny Health System