Diabetic Foot Ulcer Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 42 |
Est. completion date | April 1, 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Celia Villalba Aguilar | Toledo |
Lead Sponsor | Collaborator |
---|---|
University of Castilla-La Mancha |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Healing time | The healing time will be measured by a nurse during the days of the treatment | 12 weeks | |
Primary | Cure rate | The cure rate will be measured by a nurse during the days of the treatment | 12 weeks | |
Primary | Number of participants with adverse effects | The nurse will observe how many patients may have adverse effects. | 12 weeks | |
Primary | 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 |
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