Extracorporeal Shockwave Therapy (ESWT) of Chronic Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Ulcer area
研究概览
简要总结
Introduction:
Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain, discomfort and reduced quality of life. The development of foot ulcers places the patients at a risk of amputation. In the Danish Health Care System a substantial effort is done to prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is ongoing. The goal is to optimize wound healing and prevent amputations.
Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A small amount of energy will be deposited in the tissue when shockwaves are applied. This stimulates the cells to produce substances that generate new vessels. No side effects to ESWT have been shown.
Purpose:
The investigators want to test whether shockwave therapy can improve wound healing among diabetic patients with foot ulcers.
Hypothesis:
The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases blood flow, reduces pain, and has no side effects.
Method:
Patients who are interested in participation will be included in the study and divided by randomization into two groups of equal size. The first group is treated with ESWT in combination with regular guideline treatment. The second group is set up as control group and will only receive regular guideline treatment. The participants are examined in different ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators want to measure tissue oxygen pressure and foot sense of touch. The foot ulcers are inspected for infection at every consultation, and a swab sample will be collected at enrollment. The size of the ulcers are measured and photographed each time. The investigators will count how many foot ulcers that are completely healed during the test period and measure the sizes of the remaining foot ulcers. The patients are asked to evaluate pain related to the foot ulcer. Data concerning participants' co morbidities and use of analgesic drugs are obtained from the patient journal and by patient interview.
Significance:
ESWT should be considered a supplement to existing clinical guidelines in wound management if shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce the heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency of amputations among diabetic patients will decline by implementing new treatment options for the diabetic foot.
详细描述
[Introduction]
It is estimated that 5.5 % of the Danish population suffers from diabetes - corresponding to more than 320.000 persons. Among Danish diabetic patients the yearly incidence of foot ulcers is higher than 3.000 and the prevalence higher than 22.000. Diabetics have a lifetime risk of foot ulcers of 15 %.
Amputation is a possible consequence to having a diabetic foot ulcer. A 19-year follow-up study performed on newly diagnosed diabetics shows an incidence of amputation of 400 per 100.000 patient years.
Economical costs associated with a diabetic foot ulcer vary with the severity and treatment of the ulcer. In Denmark costs including hospitalized treatment, outpatient treatment, homecare and other social services have been calculated to (written in Danish kroner 2009):
- Healed foot ulcer without ischemia: 152.800
- Healed foot ulcer with ischemia: 252. 800
- Foot ulcer with minor amputation: 407.900
- Foot ulcer with major amputation: 597.300
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
- •Patients receiving care and treatment in OUH Wound Clinic (Odense University Hospital, Denmark) with a diabetic foot ulcer.
- •Wagner groups 1 and 2 (Wagner Ulcer Classification System)
排除标准
- •Patients with an ulcer duration of less than 2 months
- •Ulcer area less than 0,5 x 0,5 cm (or less than 0,25 cm2)
- •Patients who have had vascular surgery performed within the past 2 months
- •Patients who cannot give informed consent
- •Patients who do not read or speak danish
- •Wagner groups 3 and 4 (Wagner Ulcer Classification System)
结局指标
主要结局
Ulcer area
时间窗: 49 days after enrollment
We will use digital photos to determine 49 days ulcer area and compare to trial entry.
次要结局
- Ulcer area (only intervention group)(17-18 days after enrollment)
- Monofilament test(49 days after enrollment)
- Pain(49 days after enrollment)
- Oxygen tension(49 days after enrollment)
- Use of analgetics(49 days after enrollment)
- Side effects(49 days after enrollment)
- Complete ulcer healing(49 days after enrollment)
- Ulcer area(35 days after enrollment)
研究者
Sune Moeller Jeppesen
Medical student
Odense University Hospital