Pressure InjuryNETSMART DMNCT07027358
Clinical Investigation Evaluating the Use of NETSmart Solution , Incorporated to NETSoins Software, in the Care and Support of Elderly People Living in Nursing Homes
A study testing NETSmart software in people with Pressure Injury and Fall Prevention, run by Teranga Software at 1 site in France.
Trial summary
NETSmart software is designed to help doctors, nurses and care assistants adapt the care of elderly people living in nursing homes to the following risks: pressure injuries undernutrition interactions between different drugs falls. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Pressure Injury, Fall Prevention, Undernutrition
- What is being tested?
- NETSmart software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2024to 1 Apr 2025
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female, at least 70 years old
- Permanent resident at an investigation site for at least 6 months.
- Considered an at-risk patient, i.e. meeting at least one of the following criteria :
- Braden score < 16
- At risk of pressure ulcer according to the investigator's judgment
- At risk of undernutrition as judged by the investigator
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- Undergoing at least 6 drug treatments
- At risk of falls as judged by the investigator
- Affiliated with the French social security system
- Having given informed, dated and signed consent to participate in the investigation
Who cannot join
- Patient with a life expectancy of less than 2 months as judged by the investigator
- Patient who is participating or has participated in another investigation or study involving the use of a medical device or drug within 30 days prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
NETSmart software is designed to help doctors, nurses and care assistants adapt the care of elderly people living in nursing homes to the following risks:
- pressure injuries
- undernutrition
- interactions between different drugs
- falls. The software analyzes the information in your medical records, alerts your medical team to any points of vigilance, and suggests appropriate recommendations.
Read more
The study comprises 2 distinct phases:
- An initial 4-month phase, during which the medical staff will simply assess whether the NETSmart software's recommendations are relevant, without changing their current practice, i.e. they will continue to care for you as usual;
- A second 6-month phase, during which your caregivers will follow the software's recommendations if they feel they are relevant, and potentially adapt your care.
- Conditions
- Pressure Injury, Fall Prevention, Undernutrition, Drug Interaction
- Being tested
- NETSmart software
- Medical subject headings
- Pressure Ulcer, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NETSmart softwareDevice
Use of NETSmart software by healthcare professionals
| Study group | Role | What they receive |
|---|---|---|
| NETSmart | Experimental | Use of NETSmart software by healthcare professionals for these patients Receives: Device: NETSmart software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of clinically relevant recommandations provided by NETSmart
NETSmart Software provides recommendations to the healthcare professionals. The healthcare professionals are able to mention in the software whether the recommandations are clinically relevant or not. Data will be extracted from the software to analyze this primary outcome.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start3 Sep 2024
- Primary completion28 Feb 2025
- Study completion1 Apr 2025
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teranga Software
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RCTs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027358
- Sponsor's protocol ID
- 2024-A00812-45
- Acronym
- NETSMART DM
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Evaluating the Use of NETSmart Solution , Incorporated to NETSoins Software, in the Care and Support of Elderly People Living in Nursing Homes
- ClinicalTrials.gov ID
- NCT07027358
- Acronym / sponsor ID
- NETSMART DM / 2024-A00812-45
- Conditions
- Pressure Injury, Fall Prevention, Undernutrition, Drug Interaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Teranga SoftwareIndustry (pharma, biotech, devices)
- Collaborators
- RCTs
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 18 Jun 2025 (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.
NETSmart software is designed to help doctors, nurses and care assistants adapt the care of elderly people living in nursing homes to the following risks:
- pressure injuries
- undernutrition
- interactions between different drugs
- falls. The software analyzes the information in your medical records, alerts your medical team to any points of vigilance, and suggests appropriate recommendations.
The study comprises 2 distinct phases:
- An initial 4-month phase, during which the medical staff will simply assess whether the NETSmart software's recommendations are relevant, without changing their current practice, i.e. they will continue to care for you as usual;
- A second 6-month phase, during which your caregivers will follow the software's recommendations if they feel they are relevant, and potentially adapt your care.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NETSmart | Experimental | Device: NETSmart softwareUse of NETSmart software by healthcare professionals for these patients |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Male or female, at least 70 years old
- Permanent resident at an investigation site for at least 6 months.
- Considered an at-risk patient, i.e. meeting at least one of the following criteria :
- Braden score < 16
- At risk of pressure ulcer according to the investigator's judgment
Key exclusion criteria (2 listed)
- Patient with a life expectancy of less than 2 months as judged by the investigator
- Patient who is participating or has participated in another investigation or study involving the use of a medical device or drug within 30 days prior to inclusion
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 |
|---|---|---|
| NETSmart softwareUse of NETSmart software by healthcare professionals | Device | NETSmart |
Primary outcome
Percentage of clinically relevant recommandations provided by NETSmart
Time frame: 4 months
NETSmart Software provides recommendations to the healthcare professionals. The healthcare professionals are able to mention in the software whether the recommandations are clinically relevant or not. Data will be extracted from the software to analyze this primary outcome.
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NETSmart software in people with Pressure Injury and Fall Prevention, run by Teranga Software at 1 site in France.
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 10 inclusion and 2 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: stopped early, as of the sponsor's last update on 18 Jun 2025. 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 France. 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?
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of clinically relevant recommandations provided by NETSmart (time frame: 4 months). 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 18 Jun 2025.