Efficacy of PICO Single-use System in Chronic Ulcers

May 24, 2023 updated by: University of Castilla-La Mancha

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the size of wounds
Time Frame: 12 weeks
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
Time Frame: 12 weeks
The healing time will be measured by a nurse during the days of the treatment
12 weeks
Cure rate
Time Frame: 12 weeks
The cure rate will be measured by a nurse during the days of the treatment
12 weeks
Number of participants with adverse effects
Time Frame: 12 weeks
The nurse will observe how many patients may have adverse effects.
12 weeks
Health-related effects on quality of life.
Time Frame: 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Castilla-La Mancha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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