Efficacy of PICO Single-use System in Chronic Ulcers

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot Ulcer; Pressure Injury; Venous Ulcer; Chronic Ulcer
• Intervention / Treatment: Device: Single-use negative pressure therapy (PICO)

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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Celia Villalba Aguilar; Phone Number: 926051666; Email: celia.villalba@alu.uclm.es

Study Locations

• Spain
  • Toledo, Spain, 45003
    • Celia Villalba Aguilar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Healing time	The healing time will be measured by a nurse during the days of the treatment	12 weeks
Cure rate	The cure rate will be measured by a nurse during the days of the treatment	12 weeks
Number of participants with adverse effects	The nurse will observe how many patients may have adverse effects.	12 weeks
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

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2023
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: chronic wound; ulcer; negative pressure therapy; conventional treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Wounds and Injuries; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Varicose Ulcer; Crush Injuries
• Other Study ID Numbers: IMCU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No