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Efficacy of PICO Single-use System in Chronic Ulcers | Clinical Trials | Clareo Health

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Efficacy of PICO Single-use System in Chronic Ulcers

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

NCT05877378•University of Castilla-La Mancha

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+4 more criteria

Locations (1)

Celia Villalba Aguilar

Toledo, Spain

Key Dates

Start Date

September 15, 2023

Primary Completion Date

December 15, 2023

Completion Date

April 1, 2024

Last Updated

May 26, 2023

Enrollment

ESTIMATED participants

Conditions

Chronic UlcerVenous UlcerDiabetic Foot UlcerPressure Injury

Interventions

Single-use negative pressure therapy (PICO)

DEVICE

Contacts

Celia Villalba Aguilar

CONTACT

926051666 celia.villalba@alu.uclm.es

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 26, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Efficacy of PICO Single-use System in Chronic Ulcers

Inclusion Criteria

Exclusion Criteria

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