Efficacy of PICO Single-use System in Chronic Ulcers

NCT05877378 | Unknown DMC

• 1 other identifier: IMCU001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Ulcer; Venous Ulcer; Diabetic Foot Ulcer; Pressure Injury

Keywords

negative pressure therapy; chronic wound; ulcer; conventional treatment

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Control

NO INTERVENTION

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.

Interventions

Single-use negative pressure therapy (PICO) DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

Celia Villalba Aguilar

Toledo, 45003, Spain

Location

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot; Pressure Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Celia Villalba Aguilar

CONTACT

926051666; celia.villalba@alu.uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 26, 2023
• Study Start: September 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: April 1, 2024
• Last Updated: May 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)