Efficacy of PICO Single-use System in Chronic Ulcers
Chronic Ulcer, Venous Ulcer, Diabetic Foot Ulcer
About this trial
This is an interventional treatment trial for Chronic Ulcer focused on measuring negative pressure therapy, chronic wound, ulcer, conventional treatment
Eligibility Criteria
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.
Sites / Locations
- Celia Villalba Aguilar
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention
Control
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.
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.