A clinical trial will be carried out comparing the efficacy of PICO system based on negative pressure therapy (NPT) in adults with chronic ulcers compared to conventional treatments.
Due to the current scientific and clinical evidence shows that NPT offers guarantees as complementary care, improving healing and reducing amputations in patients with chronic ulcers, treatment with PICO single-use NPT, should be considered as the first option. This clinical trial include adults from the Hospital General Universitario of Toledo with 2 arms (intervention and control) and the intervention will last 12 weeks. The intervention proposed in the study will consist of evaluating the decrease in size, the healing rate, the adverse effects and the quality of life related to the health of the patients compared with traditional treatments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
PICO system will be applied to patients in the intervention group with diabetic foot ulcers, venous leg ulcers or pressure ulcers. This device will be changed every 7 days, until the wound is closed, or until a set period of study duration, approximately 12 weeks.
Celia Villalba Aguilar
Toledo, Spain
Change in the size of wounds
The size of the wound will be measured by a nurse using a ruler every day that the patient goes to the cure to compare de first measure from the last one.
Time frame: 12 weeks
Healing time
The healing time will be measured by a nurse during the days of the treatment
Time frame: 12 weeks
Cure rate
The cure rate will be measured by a nurse during the days of the treatment
Time frame: 12 weeks
Number of participants with adverse effects
The nurse will observe how many patients may have adverse effects.
Time frame: 12 weeks
Health-related effects on quality of life.
Patients will answer the European Quality of Life-5 Dimension. This consists of a questionnaire to measure health-related quality of life, before and after the treatment. This scale have two parts: in the first one, 0 is the best score; and 15 is the worst. In the second part (that is a pain rating scale): 0 is the worst state of health imaginable and 10 the best state of health imaginable.
Time frame: 12 weeks
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