Diabetic FootNCT03555656
Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients
A study testing Repeated intervention and Single session in people with Diabetic Foot, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Repeated intervention and Single session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 10 Jul 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Either diabetic neuropathy or previous foot ulcer
Who cannot join
- Arteriopathy of lower limbs, with ABI<0.8 or needing revascularization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Education for the Prevention of Lower Limb Ulcers in Patients With Type 2 Diabetes: Validation of an Educational Intervention Repeated Every Three Months for 2 Years.
Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention.
- Conditions
- Diabetic Foot
- Being tested
- Repeated intervention, Single session
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated interventionBehavioural
Repetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention
Single sessionBehavioural
Single 2-h group session educating patients at foot hygiene and ulcer prevention
| Study group | Role | What they receive |
|---|---|---|
| Repeated educational intervention | Experimental | Repetition every 6 months of a group educational session Receives: Behavioral: Repeated intervention |
| Control group | Active comparator | Initial single group educational session, with no repetition Receives: Behavioral: Single session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of foot ulcers
Measured: 24 months
Secondary outcomes (2)
Incidence of foot ulcers
Measured: 6 months
incidence of foot ulcers
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Mar 2018
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Why it stopped: Futility analysis suggested termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edoardo Mannucci, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555656
- Sponsor's protocol ID
- PIEDE2
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 2018
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education for the Prevention of Lower Limb Ulcers in Patients With Type 2 Diabetes: Validation of an Educational Intervention Repeated Every Three Months for 2 Years.
- ClinicalTrials.gov ID
- NCT03555656
- Acronym / sponsor ID
- PIEDE2
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility analysis suggested termination
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 13 Jun 2018 (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.
Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeated educational intervention | Experimental | Behavioral: Repeated interventionRepetition every 6 months of a group educational session |
| Control group | Active comparator | Behavioral: Single sessionInitial single group educational session, with no repetition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes mellitus
- Either diabetic neuropathy or previous foot ulcer
Key exclusion criteria (1 listed)
- Arteriopathy of lower limbs, with ABI<0.8 or needing revascularization
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 |
|---|---|---|
| Repeated interventionRepetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention | Behavioural | Repeated educational intervention |
| Single sessionSingle 2-h group session educating patients at foot hygiene and ulcer prevention | Behavioural | Control group |
Primary outcome
Incidence of foot ulcers
Time frame: 24 months
2 secondary outcomes
Incidence of foot ulcers
Time frame: 6 months
incidence of foot ulcers
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Futility analysis suggested termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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 Repeated intervention and Single session in people with Diabetic Foot, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 2 inclusion and 1 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 14 Jan 2021. 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 Italy. 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: Futility analysis suggested termination). 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?
Incidence of foot ulcers (time frame: 24 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 14 Jan 2021.