IPCOTT - Intermittent pneumatic compression of the thigh for the treatment of lower extremity wounds: a randomized control trial.
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A CE-certified class IIa medical device WoundExpressTM is used.
The body's own calf muscle pump (venous pump) makes a significant contribution to blood circulation in the legs. In persons with venous disease and non-functioning venous valves, this mechanism is disturbed, and immobility, e.g. as a result of joint complaints, has an aggravating effect here.
In the advanced stage of venous disease, fluid accumulation in the tissue (phleboedema) and chronic skin changes occur, leading to skin lesions and ultimately ulceration. In addition to phase-appropriate wound treatment, the most important cornerstone in therapy is compression. Compression bandages or compression stockings exert compressive pressure on the tissue, especially when the patient is moving; this promotes blood flow back to the heart.
Deep and poorly healing wounds are called leg ulcers. Their treatment can take months or even years. To achieve improved decongestion, apparative compression methods such as intermittent pneumatic compression (IPC) are available. In IPC, an automatic control system alternately pumps or deflates air into a treatment cuff so that pressure and relaxation are felt alternately.
Aims and Procedures
Although there is evidence that IPC is effective, previous devices are not yet optimally suited for practical use. Technical improvements are needed to increase adoption.
The goal of the IPCOTT study is to determine whether a new IPC device, known as WoundExpressTM, can help heal leg ulcers. In particular, the efficacy of the treatment, patient satisfaction, and safety and cost-effectiveness will be further investigated.
- Randomized control trial
- Inclusion: 160 affected individuals with at least one venous leg ulcer (total for all study sites)
- Study duration: 18 weeks per participant:in
- Intervention group uses the WoundExpress device daily for 2h in addition to their normally ordered therapy
- Observation category includes wound size (measurement, photo)
- Survey on well-being/quality of life and limitations in everyday life
- Control group is given the opportunity to try out the device for 18 weeks after the end of the study