Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
42 participants
INTERVENTIONAL
2023-09-15
2024-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
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.
Single-use negative pressure therapy (PICO)
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.
Control
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.
No interventions assigned to this group
Interventions
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Single-use negative pressure therapy (PICO)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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University of Castilla-La Mancha
OTHER
Responsible Party
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Locations
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Celia Villalba Aguilar
Toledo, , Spain
Countries
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Central Contacts
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Other Identifiers
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IMCU001
Identifier Type: -
Identifier Source: org_study_id
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