Efficacy of PICO Single-use System in Chronic Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05877378
• Other study ID #: IMCU001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2023
• Source: University of Castilla-La Mancha
• Contact: Celia Villalba Aguilar
• Phone: 926051666
• Email: celia.villalba[@]alu.uclm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: April 1, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Ulcer
• Crush Injuries
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Pressure Injury
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	Celia Villalba Aguilar	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the size of wounds	The size of the wound will be measured by a nurse using a ruler every day that the patient goes to the cure to compare de first measure from the last one.	12 weeks
Primary	Healing time	The healing time will be measured by a nurse during the days of the treatment	12 weeks
Primary	Cure rate	The cure rate will be measured by a nurse during the days of the treatment	12 weeks
Primary	Number of participants with adverse effects	The nurse will observe how many patients may have adverse effects.	12 weeks
Primary	Health-related effects on quality of life.	Patients will answer the European Quality of Life-5 Dimension. This consists of a questionnaire to measure health-related quality of life, before and after the treatment. This scale have two parts: in the first one, 0 is the best score; and 15 is the worst. In the second part (that is a pain rating scale): 0 is the worst state of health imaginable and 10 the best state of health imaginable.	12 weeks