NCT05877378

Efficacy of PICO Single-use System in Chronic Ulcers

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Ulcer
• Venous Ulcer
• Diabetic Foot Ulcer
• Pressure Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-15
• Primary completion: 2023-12-15
• Completion: 2024-04-01
• First posted: 2023-05-26
• Last updated: 2023-05-26

Locations

1 site across 1 country: Spain