Evaluation of the Clinical Utility, Efficacy and Safety of a Novel Medical Device (Carbothera) in the Treatment of Foot Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Ankle Brachial Index (ABI)/Blood Flow
研究概览
简要总结
Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with kidney disease. Patients with kidney disease receiving dialysis have an increased prevalence of critical limb ischemia. Carbon dioxide (CO2) foot bathing has been reported to improve subcutaneous microcirculation. The proposed clinical study will evaluate the therapeutic potential of CO2 enriched water (produced by the Carbothera device) on treating foot ulcers in patients with critical limb ischemia and undergoing hemodialysis. Forty individuals how have a distal extremity ulcer who are currently undergoing hemodialysis will participate in this study.
详细描述
This is a multi-centered, placebo controlled and randomized clinical study designed to evaluate the therapeutic potential of CO2 enriched water on the treatment of distal extremity (foot) ulcers in patients with critical limb ischemia undergoing hemodialysis. Study participants will be patients receiving dialysis at two local hospitals in Winnipeg and will have been diagnosed with CLI and foot ulceration. Patients will be randomized to receive either treatment with CO2-enriched tap water, 1,000-1200 ppm CO2 (TREATMENT GROUP), or non-enriched tap water (CONTROL GROUP), bath therapy at 37ºC on the same day as dialysis (typically 3 times/wk), for 15 min for 4 months,. Blood (approximately 20 ml) will also be collected at baseline and at the end of every month of the treatment period (for a total of 5 collections) for the measurement of the different biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Male and female participants ≥ 18 years of age with at least one distal extremity ulcer (arterial ischemic ulcer).
- •No acute medical illness and on conventional medical management prior to Carbothera.
- •Willingness and ability to provide written informed consent
排除标准
- •DVT or PE within 12 months.
- •Subjects with known active cancer, HIV, hepatitis B virus, hepatitis C virus, human transmissible spongiform encephalopathy, Treponema pallidum.
- •Subjects who are deemed to have an infection of the distal extremity ulcer.
- •Women who are pregnant
- •Unstable angina.
- •Acute MI within 1 month.
- •Stroke within 1 month.
- •Patient scheduled for revascularization during the 4-month intervention period.
研究组 & 干预措施
CO2-Enriched Tap Water (Carbothera)
CO2-enriched tap water (CO2 concentration, 1000-1200 ppm) maintained at a temperature of 37˚C. Tap water will be enriched with CO2 by the investigational Carbothera device.
干预措施: CO2-Enriched Tap Water (Carbothera) (Procedure)
Non-CO2-Enriched Tap Water
Non-CO2-enriched tap water (i.e. normal tap water) maintained at a temperature of 37˚C.
干预措施: Non-CO2-Enriched Tap Water (Procedure)
结局指标
主要结局
Changes in Ankle Brachial Index (ABI)/Blood Flow
时间窗: 4 Months
A continuous wave, hand held Doppler machine will be used with a blood pressure cuff and a conventional sphygmomanometer to measure the systolic pressure in both the posterior tibial (PT) and dorsalis pedis (DP) arteries. If no PT or DP arterial signals are found, the anterior tibial and/or peroneal artery pressure will be recorded. The ankle systolic pressure and brachial systolic blood pressure will be calculated as ankle systolic pressure/bronchial systolic pressure (ABI). The subject will be asked to rest supine for 10 minutes before ABI measurements. Brachial systolic and diastolic pressures as well as heart rate will be measured. Measurement of ABI will be conducted at Baseline (Day 1), and at weeks 4, 8, 12 and 16.
Changes in Ulceration Area, Volume, Depth and Rate
时间窗: 4 months
Measurement of ulceration area, volume, depth and rate will be completed at Baseline (Day 1), Week 4, Week 8, Week 12 and Week 16 using an approved (Health Canada) portable hand-held 3D digital wound imaging camera (SilhouetteStar from Aranz Medical, New Zealand).
次要结局
- Changes in Degree of Rest Pain(4 Months)
- Changes Limb Oxygenation(4 Months)
- Changes in Inflammatory Markers: TNFα, IL-6 and C - reactive protein(4 Months)
- Changes in Markers of Glucose Handling: HbA1c and Fasting Blood Glucose(4 Months)
- Changes in Lipid Profile(4 Months)
- Changes in Angiogenesis Marker: vascular endothelial growth factor (VEGF)(4 Months)
- Changes in Use of Bespoke Footwear and/or ability to Walk Barefoot(4 Months)
- Incidence of Amputation(4 Months)
- Use of Antibiotics Indicated for the Ulcer Treatment(4 Months)