Intermittent Pneumatic Compression of the Thigh for the Treatment of Lower Limb Wounds: a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 10
- 主要终点
- Determine the effect of thigh administered IPC on the healing of lower limb wounds of venous or mixed etiology
研究概览
简要总结
Study Summary
A leg ulcer is a long-lasting (chronic) sore that takes more than two weeks to heal. The majority of leg ulcers are caused either by problems with the veins in the legs; these are called 'venous leg ulcers' (VLU), or a combination of both venous and arterial disease which affects the veins and arteries in the leg; these are called 'mixed aetiology ulcers'(MLU). Venous and mixed aetiology leg ulcers are usually treated by applying a simple non-stick dressing to the ulcer with a firm compression bandage applied on top. These bandages are designed to squeeze the legs and encourage blood flow towards the heart. Before this treatment starts, a patient may undergo tests to check the flow of blood in the leg arteries is adequate. This ensures that compression bandaging can be safely applied to assist wound healing without compromising arterial blood flow.
Most venous and mixed aetiology leg ulcers heal within three to four months if they're treated by a healthcare professional trained in compression therapy for leg ulcers. However, some ulcers can be more problematic and may persist for many months or even years despite being treated with the gold standard treatment of compression bandages. We therefore need to find more ways of helping these problematic ulcers to heal.
Intermittent Pneumatic Compression (or IPC) is another way of compressing legs to try and improve the circulation. IPC consists of a sleeve or garment which is applied to the leg. The sleeve is connected to a pump which gently inflates and then deflates it to squeeze the leg in a massage like manner.
The IPCOTT study aims to find out if a new IPC device, known as the WoundExpress can help to heal leg ulcers. The WoundExpress has a sleeve that patients put around the thigh, like the one applied to the arm when people have their blood pressure taken. Users need to be either sitting with their legs raised or lying down when using the device. Pressing the 'start' button on the pump causes the sleeve to automatically inflate with air for 2 minutes, until it reaches a pressure of 60 mm/Hg (this is low compared to the pressure used when measuring blood pressure; most patients find it very gentle and comfortable). After the 2-minute inflation, the sleeve will automatically deflate for another 2 minutes, where no compression is applied to the thigh. These 4-minute inflation and deflation cycles will repeat whilst the device is in use.
People who take part in the study will be randomly allocated to Group A or Group B. Patients in Group A will continue to receive their usual wound care but will also be provided with a WoundExpress device to use for 2 hours per day for a 16-week period. Patients in Group B will continue to receive their standard wound treatment only for the 16-week study period (patients in Group B will be offered the chance to use the WoundExpress device for a 16-week period after the study has ended). All patients taking part in the study will be asked to attend their Wound Clinic for a study review once every two weeks during the study period. At these visits, a research nurse will take measurements and photographs of the ulcer(s) and participants will also be asked some questions about how they have been feeling since using the device. Patients who have been given a WoundExpress device will also be asked to keep a diary recording when they use the device and how they found it.
When the study is complete, results will be analyzed to find out if there was any difference in ulcer healing rates between Group A and Group B.
详细描述
Clinical Problem:
A leg ulcer is defined as the loss of skin below the knee on the leg or the foot, which takes more than two weeks to heal. Leg ulcers are the most common wound type in the community in the UK with a prevalence rate of approximately of 0.45/1000 in men and 0.56/1000 in women, increasing to 8.29/1000 in men and 8.06/1000 in women aged over 85 years old. Leg ulcers of venous origin account for approximately 70% of individuals with leg ulcers, with 10-20% being due to a combination of venous and arterial disease, often referred to as mixed leg ulcers (MLU).
Leg ulceration represents a significant source of morbidity with adverse physical, social and psychological sequalae. With appropriate treatment, some ulcers heal successfully within a few weeks, however many persist for months and even several years. The annual cost of managing patients with venous leg ulcers alone in Wales is £7,706 per patient per annum, which translates to an annual cost of over £2 billion when extrapolated to the United Kingdom (UK) population.
Current Treatment Compression therapy in the form of graduated, multi-layered bandaging, is widely accepted as the treatment of choice and gold standard therapy for the prevention and management of VLU. Compression therapy can also be recommended for mixed aetiology wounds where vascular assessment has been completed and there is no evidence of severe peripheral arterial disease (PAD) whereby compression therapy would be contraindicated. Patients with mixed etiology ulceration of the lower limb with an ankle brachial pressure index (ABPI) of >0.5 and an absolute ankle pressure >60 millimeters of mercury (mmHg) were able to receive inelastic compression up to 40 mmHg without restricting arterial perfusion. Other published guidance suggests a more conservative approach to compression with mixed disease with moderate PAD, utilizing a reduced level delivering approximately 20 - 30 millimeters of mercury compression at the ankle or the use of mild to moderate compression incorporating pressures <20 millimeters of mercury up to 40 millimeters of mercury.
However, a proportion of wounds do not progress towards healing despite receiving this gold standard treatment and furthermore some patients cannot tolerate wearing continual compression bandaging. A study showed that of 440 patients with VLUs who were in gold standard compression, 48% had not healed within 12 months. Comparable healing rates between VLU and MLU treated with reduced compression have been previously demonstrated.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Presence of at least one hard to heal*, venous or mixed (of both venous and arterial origin) aetiology lower limb wound
- •ABPI ≥ 0.6, or, where an ABPI measure is not viable, use of locally-approved alternative assessments to rule out significant peripheral arterial disease i.e. doppler auscultation, toe pressure assessment (Absolute Toe Pressure ≥40mmHg ) or arterial imaging
- •Has received high static compression therapy (in the form of bandages, wraps or hosiery) during the preceding 4 weeks and is willing to continue receiving appropriate static compression therapy for their ulcer aetiology for the duration of the study
- •Receiving standard wound care as per investigator discretion which will continue regardless of study participation
- •Able and willing to give informed consent for participation in study
- •Able to self-apply IPC garment (supplied) and connect to an electrically operated pump at home for two hours daily for a 16 week period
- •Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo a pregnancy test at screening
- •Failure of wound to progress towards healing (as indicated by decrease in surface area by ≥ 25%) in preceding month, despite appropriate and adequate compression therapy.
排除标准
- •Wound surface area ≥ 100cm2
- •Wound duration ≤ 2 months or ≥ 5 years
- •Diabetic patients with recent HbA1c >8.5
- •Known or suspected deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis and acute infections of the skin, such as cellulitis
- •Decompensated/severe congestive cardiac failure, pulmonary oedema associated with significant limb oedema or any condition where an increase of fluid to the heart may be detrimental
- •Severe arteriosclerosis or other ischemic vascular disease
- •Leg ulcers without a venous component to their aetiology (e.g., arterial or rheumatoid) or significant peripheral vascular disease which contraindicates compression (ABI < 0.6 or Absolute Toe Pressure <40mmHg)
- •Known malignancy
- •Patient receiving any other adjunctive wound therapy such as heat, topical negative therapy, biotherapy
- •Current participation in any other clinical trial
- •Patient likely to miss more than five days of therapy (e.g. for planned holiday)
- •Thigh circumference >90cm (maximum garment size)
- •Any wounds, infection or dermatological conditions that would be adversely affected by placement of the thigh garment
- •Subject is pregnant or breast-feeding
- •Ɨ within preceding 3 months
结局指标
主要结局
Determine the effect of thigh administered IPC on the healing of lower limb wounds of venous or mixed etiology
时间窗: 16 weeks
Assess percentage change to wound surface area of the reference ulcer following a 16-week intervention period as assessed by the percentage of change in wound surface. This will be calculated using the measurements from wound photographs and by dividing the change by the baseline area. A percentage below zero will indicate an increase in wound size and a percentage above zero indicates a reduction in wound size at week 16 compared with baseline.
次要结局
- Assess safety of IPC therapy(16 weeks)
- Assess the effect of IPC on patient experience of wound related pain(16 weeks)
- Assess the effect of IPC on patient quality of life(16 weeks)
- Assess patient acceptability of IPC therapy(16 weeks)
- Assess the cost effectiveness of IPC as a treatment for venous and mixed etiology leg ulcers(16 weeks)
- Determine the proportion of patients with wound closure at week 16(16 weeks)