Clinical trial NCT05877378: Efficacy of PICO Single-use System in Chronic Ulcers
Official title: Efficacy of Single-use Negative Pressure Therapy With PICO System in Chronic Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Ulcer
Venous Ulcer
Diabetic Foot Ulcer
Pressure Injury
Keywords: negative pressure therapy
chronic wound
ulcer
conventional treatment
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Change in the size of wounds
timeFrame: 12 weeks
measure: Healing time
timeFrame: 12 weeks
measure: Cure rate
timeFrame: 12 weeks
measure: Number of participants with adverse effects
timeFrame: 12 weeks
measure: Health-related effects on quality of life.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Celia Villalba Aguilar
Study officials:
References: