Efficacy of PICO Single-use System in Chronic Ulcers

University of Castilla-La Mancha

Status: Not yet enrolling

Conditions: Venous Ulcer; Pressure Injury; Chronic Ulcer; Diabetic Foot Ulcer

Treatments: Device: Single-use negative pressure therapy (PICO)

Study type: Interventional

Funder types: Other

Identifiers

NCT05877378

IMCU001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Device: Single-use negative pressure therapy (PICO)

Control

No Intervention group

Description:

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.