Efficacy of PICO Single-use System in Chronic Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Single-use Negative Pressure Therapy With PICO System in Chronic Ulcers

Conditions
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Chronic Ulcer, Venous Ulcer, Diabetic Foot Ulcer, Pressure Injury

Intervention / Treatment
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* Device: Single-use negative pressure therapy (PICO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes over 18 years. Patients with chronic ulcers: venous leg ulcer, diabetic foot ulcer or pressure ulcers. Patients capable of complying with the protocol instructions and signing the informed consent (IC) or with limited capacity to act, in which case their relatives would be informed, who would be the ones who would grant the signed informed consent. Acceptable state of health. Exclusion Criteria: Malignant ulcers. Ulcers with abundant exudate. Non-modifiable anatomical location to create hermetic seal of the dressing. Suspected or known allergy to components of TPN systems. Pregnancy. Serious cardiovascular diseases. Diagnosis of vasculitis or claudication. Current administration of systemic chemotherapy or corticosteroids. Having received prior treatment with TPN or hyperbaric oxygen in the 7 days prior to screening. Leukopenia, thrombocytopenia, anemia, increased bilirubin or three times the level of liver enzymes. Deep venous thrombosis. Refusal or inability to tolerate compression therapy, exposure of muscles, tendons or bone. Diagnosis of active Charcot foot syndrome. Malnutrition or eating disorders.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group measurements will be carried out every 7 days, since the PICO system lasts from 7 to 14 days, except when the ulcer presents infection, which will be cured every 2-3 days. | Device: Single-use negative pressure therapy (PICO)<br>* 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.<br>|
| No Intervention: Control<br>The control group measurements will be carried out every 7 days, except when the ulcer is infected, when the cure will be carried out every 2-3 days. This group (GC) will be treated mainly with betadine and sugar, or other treatments such as alginate patches, corticosteroids, Aquacel, Celestoderm or Mepitel. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| Healing time | The healing time will be measured by a nurse during the days of the treatment | 12 weeks | 
| Cure rate | The cure rate will be measured by a nurse during the days of the treatment | 12 weeks | 
| Number of participants with adverse effects | The nurse will observe how many patients may have adverse effects. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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negative pressure therapy, chronic wound, ulcer, conventional treatment