Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05877378 | Not yet recruiting | Chronic Ulcer

Efficacy of PICO Single-use System in Chronic Ulcers
Sponsor:

University of Castilla-La Mancha

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.

Condition or disease

Chronic Ulcer

Venous Ulcer

Diabetic Foot Ulcer

Pressure Injury

Intervention/treatment

Single-use negative pressure therapy (PICO)

Phase

Not Applicable

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
Estimated Enrollment : 42 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Efficacy of Single-use Negative Pressure Therapy With PICO System in Chronic Ulcers
Actual Study Start Date : September 15, 2023
Estimated Primary Completion Date : December 15, 2023
Estimated Study Completion Date : April 1, 2024
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.

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.
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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.
Efficacy of PICO Single-use System in Chronic Ulcers

Location Details

Please Choose a site

Efficacy of PICO Single-use System in Chronic Ulcers

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Spain,

Celia Villalba Aguilar

Toledo, Spain, 45003