A Sham Controlled Study to Compare the Effectiveness of Three Different Power Levels of PEMF Devices in the Treatment and Resolution of Venous Stasis Leg Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Specific pulsed electromagnetic fields improves the healing trajectory of venous stasis ulcers.
研究概览
简要总结
The purpose of this study is to determine the clinical effectiveness of a low-power PEMF device, a medium-power PEMF device and a high-power PEMF device as compared to a sham device to treat leg ulcers resulting from venous stasis ("VSLU").
详细描述
This study will demonstrate whether PEMF therapy is an effective adjunct treatment to the traditional treatment protocol used for the resolution of VSLU and of the pain associated with them. This is a 4 arm study done by comparing the outcomes of treatment with a low-power PEMF device, a medium-power PEMF device and a high-power PEMF device against those obtained from the control group treated with a sham PEMF device.
A device usability study is included in the study protocol to evaluate the participants' understanding of the device packaging, the User Manual, the device labeling, the controls and the directions for use. An un-blinded assistant ("UA") will manage the device usability study and hand out all informational literature and instructions to each participant, in accordance with the randomization protocol. Participants' success will be rated and their perception on the ease of use and how to make the device easier to use will be solicited.
Safety precautions and contraindications are specifically defined, and adverse/ unexpected events and reactions, if any, will be documented as they arise.
The primary aims of the study are to assess the effects of 16 weeks of PEMF treatment on the VSLU with one of three PEMF devices of different power levels against a sham PEMF device. The study has 3 specific aims:
Aim 1 (Primary) Determine if the use of specific PEMFs affect the time for healing trajectory of VSLU. Healing trajectory over the 16 week of the study protocol will be measured as the area under the curve for total lesion area expressed as a percentage of the baseline area.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must also have normal cognitive and communicative abilities to provide comprehensive information for:
- •Health history questionnaire and Your Health in General ("SF-36")
- •The National Initiative on Pain Control pain assessment scales (NIPC scales). The NIPC scales are comprised of four complementary pain assessment rating scales, the Wong-Baker FACES Pain Rating Scale, Numeric Rating Scale (NRS), a pain location chart and a Pain Quality Assessment Scale© (PQAS©)
排除标准
- •Inability to obtain informed consent from participant
- •Prisoners or convicts
- •Hemorrhagic tendencies, Purpura, hemophilia, or any cardiovascular diseases
- •Severe anemia, Hemoglobin < 8.5
- •Severe hypoalbumenemia, serum albumen , 2.6
- •Poorly controlled diabetes, A1cHgb > 12
- •Severe renal failure - serum creatinine > 2.5 or hemodialysis
- •Severe hepatic insufficiency: know cirrhosis, any degree of ascites, serum transaminases more than 3 times the upper limit of normal
- •Pregnancy - women of childbearing potential must agree to use adequate contraception during the study
- •HIV infection unless on retroviral therapy and viral load undetectable by PCR
- •Severe hypoxemia - chronic oxygen or ventilator therapy
- •Known cryoglobulinemia
- •Systemic antibiotic therapy for any indication within 5 days of screening
- •A fracture to the lower extremities in the last 6 weeks
- •Within 24 hours of any surgery or 2 weeks of surgery on internal organs
- •Critically ill patients, patients hospitalized and patients who received transplants in past 2 months or patients in whom over-medication may be contraindicated
- •Active chemotherapy, cancer or malignant tumors
- •Any metal screws, pins and/or metallic implants within 15 inches of the VSLU
- •Participants with specific ulcers originating from sickle cell anemia or clinically significant infections as determined by ulcer culture
- •A history of difficult venipuncture for obtaining blood specimens
- •Current use of systemic agents or immunosuppressive therapy that may influence wound healing, such as Prednisone, Dexamethasone. Topical steroids to a maximum level of 25 mg Hydrocortisone daily applied no closer than 2.5 cm from the VSLU margin. Non steroidal anti-inflammatory drugs (NSAIDs) are not allowed except Ibuprofen maximum daily dose of 1800 mg, Acetaminophen maximum daily dose of 2600 mg (with or w/o opiates) and Naproxen maximum daily dose of 1000 mg
- •Current participation in any other clinical trial or study
- •Current involvement in a medical litigation or malpractice lawsuit.
结局指标
主要结局
Specific pulsed electromagnetic fields improves the healing trajectory of venous stasis ulcers.
时间窗: The data necessary to establish the healing trajectory is collected over 16 weeks
The healing trajectory will be evaluated after 16 weeks of PEMF treatment with one of three PEMF devices of different power level or a sham device. Leg ulcer area will be documented and a healing timeline will be defined. If healing is complete prior to the end of the 16-week treatment protocol, the RA will compile the length of time required for healing.
次要结局
- Blood and serum levels of three inflammatory cytokines are affected by the use of specific pulsed electromagnetic fields.(The blood and serum samples are collected over 16 weeks)
- Venous leg ulcer pain is affected by the use of specific pulsed electromagnetic fields.(The assessments are collected over 16 weeks)