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Efficacy of PICO Single-use System in Chronic Ulcers

Primary Purpose

Chronic Ulcer, Venous Ulcer, Diabetic Foot Ulcer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Single-use negative pressure therapy (PICO)
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Ulcer focused on measuring negative pressure therapy, chronic wound, ulcer, conventional treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Celia Villalba Aguilar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 11, 2023
Last Updated
May 24, 2023
Sponsor
University of Castilla-La Mancha
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1. Study Identification

Unique Protocol Identification Number
NCT05877378
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ulcer, Venous Ulcer, Diabetic Foot Ulcer, Pressure Injury
Keywords
negative pressure therapy, chronic wound, ulcer, conventional treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Single-use negative pressure therapy (PICO)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the size of wounds
Description
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.
Time Frame
12 weeks
Title
Healing time
Description
The healing time will be measured by a nurse during the days of the treatment
Time Frame
12 weeks
Title
Cure rate
Description
The cure rate will be measured by a nurse during the days of the treatment
Time Frame
12 weeks
Title
Number of participants with adverse effects
Description
The nurse will observe how many patients may have adverse effects.
Time Frame
12 weeks
Title
Health-related effects on quality of life.
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celia Villalba Aguilar
Phone
926051666
Email
celia.villalba@alu.uclm.es
Facility Information:
Facility Name
Celia Villalba Aguilar
City
Toledo
ZIP/Postal Code
45003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of PICO Single-use System in Chronic Ulcers

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