Intermittent Pneumatic Compression of the Thigh

Study SummaryA 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.

Inclusion Criteria:Age ≥ 18 yearsPresence of at least one hard to heal*, venous or mixed (of both venous and arterial origin) aetiology lower limb woundABPI ≥ 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 imagingHas 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 studyReceiving standard wound care as per investigator discretion which will continue regardless of study participationAble and willing to give informed consent for participation in studyAble to self-apply IPC garment (supplied) and connect to an electrically operated pump at home for two hours daily for a 16 week periodFemales 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 screeningFailure of wound to progress towards healing (as indicated by decrease in surface area by ≥ 25%) in preceding month, despite appropriate and adequate compression therapy.Exclusion Criteria:Wound surface area ≥ 100cm2Wound duration ≤ 2 months or ≥ 5 yearsDiabetic patients with recent HbA1c >8.5Known or suspected deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis and acute infections of the skin, such as cellulitisDecompensated/severe congestive cardiac failure, pulmonary oedema associated with significant limb oedema or any condition where an increase of fluid to the heart may be detrimentalSevere arteriosclerosis or other ischemic vascular diseaseLeg 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 malignancyPatient receiving any other adjunctive wound therapy such as heat, topical negative therapy, biotherapyCurrent participation in any other clinical trialPatient 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 garmentSubject is pregnant or breast-feedingƗ within preceding 3 months