Chronic UlcerNCT05877378
Efficacy of PICO Single-use System in Chronic Ulcers
A study testing Single-use negative pressure therapy (PICO) in people with Chronic Ulcer and Venous Ulcer, run by University of Castilla-La Mancha at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Ulcer, Venous Ulcer, Diabetic Foot Ulcer
- What is being tested?
- Single-use negative pressure therapy (PICO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Ulcer, Venous Ulcer, Diabetic Foot Ulcer, Pressure Injury
- Being tested
- Single-use negative pressure therapy (PICO)
- Keywords
- negative pressure therapy, chronic wound, ulcer, conventional treatment
- Medical subject headings
- Varicose Ulcer, Diabetic Foot, Pressure Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Healing time
The healing time will be measured by a nurse during the days of the treatment
Measured: 12 weeks
Cure rate
The cure rate will be measured by a nurse during the days of the treatment
Measured: 12 weeks
Number of participants with adverse effects
The nurse will observe how many patients may have adverse effects.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start15 Sep 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877378
- Sponsor's protocol ID
- IMCU001
- Status last verified
- Jan 2023
- First submitted
- 11 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Single-use Negative Pressure Therapy With PICO System in Chronic Ulcers
- ClinicalTrials.gov ID
- NCT05877378
- Acronym / sponsor ID
- IMCU001
- Conditions
- Chronic Ulcer, Venous Ulcer, Diabetic Foot Ulcer, Pressure Injury
- Keywords
- negative pressure therapy, chronic wound, ulcer, conventional treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Single-use negative pressure therapy (PICO)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention |
Primary outcome
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.
Healing time
Time frame: 12 weeks
The healing time will be measured by a nurse during the days of the treatment
Cure rate
Time frame: 12 weeks
The cure rate will be measured by a nurse during the days of the treatment
Number of participants with adverse effects
Time frame: 12 weeks
The nurse will observe how many patients may have adverse effects.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-use negative pressure therapy (PICO) in people with Chronic Ulcer and Venous Ulcer, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celia Villalba Aguilar (926051666, celia.villalba@alu.uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the size of wounds (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.