Diabetes ComplicationsNCT07329491
Impact of an Educational Intervention on Ulcer Incidence, Knowledge, Self-Care, and Quality of Life in Diabetic Foot Syndrome
A study testing Structured education intervention and Standard podiatry care in people with Diabetes Complications and Diabetes Education, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
This randomized clinical trial assessed the impact of a structured educational intervention in patients with diabetic foot syndrome. Forty-two participants were allocated to an intervention group-receiving two specialist-led educational sessions-or to a control group with standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Complications, Diabetes Education, Diabetes Foot Care
- What is being tested?
- Structured education intervention and Standard podiatry care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years old) with a confirmed diagnosis of diabetes mellitus (Type
- 1 or Type 2).
- Classified at any risk level for diabetic foot ulceration according to the IWGDF Foot Risk Classification.
- Able to walk independently and capable of participating in educational activities and evaluations.
- Able to understand study procedures and voluntarily provide written informed consent.
- Willing to attend educational sessions (intervention group) and complete all scheduled assessments.
Who cannot join
- Decline to participate or inability to provide written informed consent.
- Presence of cognitive impairment, neurological disorders, or any condition that limits comprehension or adherence to study procedures.
- Severe physical or functional limitations preventing participation in foot assessments or educational sessions.
- Active diabetic foot ulcer or ongoing treatment for an acute foot wound at enrollment.
- Participation in another clinical trial that could interfere with study outcomes.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Enfermería, Fisioterapia y Podología de la Universidad Complutense de Madrid
Madrid, 28040
About this study
Official title: Evaluation of the Impact of a Structural Educational Intervention on the Prevention of Diabetic Foot Syndrome: A Ramdomized Clinical Trial Using a Mixed Methods Approach
This randomized clinical trial assessed the impact of a structured educational intervention in patients with diabetic foot syndrome. Forty-two participants were allocated to an intervention group-receiving two specialist-led educational sessions-or to a control group with standard care.
The intervention produced significant improvements in knowledge and self-care after the first session, with stable retention and cumulative benefits by the end of the program. Clinically relevant improvements were also observed in skin condition and preventive foot-care behaviors such as appropriate footwear, socks, and nail-cutting technique.
Read more
Qualitative data showed that diabetes and DFS strongly affect quality of life, while group-based education enhanced peer support, sense of control, and adherence to preventive care. No ulcers occurred during the six-month follow-up.
Structured educational interventions are effective and rapidly beneficial, though larger studies with longer follow-up are needed to confirm their impact on ulcer prevention.
Read the detailed description
This randomized clinical trial evaluated the impact of a structured educational intervention on ulcer incidence, patient knowledge, self-care practices, and quality of life in individuals with diabetic foot syndrome (DFS). A total of 42 patients were assigned either to an intervention group-which received two monthly educational sessions delivered by a specialist-or to a control group receiving standard care.
The intervention followed IWGDF recommendations and covered topics such as DFS pathophysiology, glycemic control, ulcer risk identification, and evidence-based preventive strategies. Knowledge was assessed at four time points using a validated questionnaire. Self-care practices were assessed through clinical observation, and skin condition through the CERLCP scale. A qualitative analysis using focus groups explored patients' subjective experiences.
No new foot ulcers developed during the six-month follow-up. The intervention group demonstrated significant improvements in knowledge after the first session, with stable retention between sessions and cumulative gains by the end of the program. Marked improvements were also observed in self-care behaviors, particularly appropriate footwear and socks, nail-cutting technique, and reduction of hyperkeratosis. Skin quality improved with clinically meaningful effect sizes.
The qualitative findings showed that diabetes and DFS substantially affect patients' physical, emotional, social, and economic well-being. The educational intervention enhanced peer support, sense of control, and adherence to preventive self-care.
This study demonstrates that a structured educational intervention-even a single session-can produce rapid and meaningful improvements in knowledge and self-care practices. Larger studies with longer follow-up are required to determine its effectiveness in reducing ulcer incidence over time.
- Being tested
- Structured education intervention, Standard podiatry care
- Keywords
- Diabetic foot, diabetic foot ulcer, health education, self care, quality of life
- Medical subject headings
- Diabetes Complications, Diabetic Foot, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured education interventionBehavioural
Participants in the intervention arm received a structured educational program delivered face-to-face in small groups by a healthcare professional specialized in diabetic foot prevention. The program comprised two monthly sessions (2 hours each) following IWGDF recommendations. Session topics included diabetic foot pathophysiology, ulcer risk identification, glycaemic control, daily foot inspection, proper footwear and sock selection, nail care, skin care (hydration/creams) and recognition of warning signs. Teaching methods combined short lectures, visual materials, case examples and group discussion; participants received printed take-home guidance. Knowledge, self-care behaviours and foot skin condition were assessed pre/post intervention and participants were followed for 6 months to monitor outcomes. Structured diabetic foot education.
Standard podiatry careOther
Routine podiatry care provided during regular chiropody consultations at a specialised unit, including clinical foot assessment and usual advice, without any structured or formal educational program.
| Study group | Role | What they receive |
|---|---|---|
| Structured diabetic foot education program | Experimental | Participants attended two structured, group-based educational sessions on diabetic foot prevention based on IWGDF guidelines, delivered by a specialist, including foot self-care, footwear, and risk identification. Receives: Behavioral: Structured education intervention |
| Standard podiatry care without structured education | Active comparator | Participants received standard care during routine chiropody consultations at a specialised unit, without additional structured educational intervention. Receives: Other: Standard podiatry care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new foot ulceration
Proportion of participants developing a new diabetes-related foot ulcer (yes/no), defined as a full-thickness skin break on the foot. Assessed through clinical examination and medical record review during routine follow-up visits.
Measured: Baseline and 6-month follow-up
Secondary outcomes (4)
Knowledge score (6-item questionnaire)
Change in the total score of a validated six-item diabetic foot knowledge questionnaire assessing understanding of diabetic foot pathophysiology, ulcer risk factors, appropriate footwear and sock characteristics, and preventive self-care practices.
Scale details: The questionnaire consists of 6 dichotomous items (correct/incorrect), with a total score range from 0 to 6 points. Higher scores indicate greater knowledge and a better outcome.
Measured: Baseline, immediately after the first educational session, 30 days later before the second session, and immediately after the second educational session.
Self-care behaviors (footwear, socks, toenail trimming, orthoses, maceration, hyperkeratosis)
Change in individual dichotomous self-care indicators (appropriate footwear, appropriate socks, correct toenail trimming, use of orthoses, interdigital maceration, hyperkeratosis), assessed through direct clinical observation using a standardized checklist.
Measured: Baseline at the first educational session and immediately after the second educational session, 30 days later.
Sking quality. Questionnaire for the Evaluation of Injury Risk and Skin Quality in Diabetic Foot Sindrome (QERSQ).
Change in total Questionnaire for the Evaluation of Injury Risk and Skin Quality in Diabetic Foot Sindrome, score evaluating skin condition of the dorsal foot, plantar surface and heel. Higher scores indicate worse skin condition. Score range 0-12
Measured: Baseline, immediately after the first educational intervention, and immediately after the second educational intervention at 30 days.
Quality of life related to diabetic foot syndrome (qualitative assessment)
Qualitative evaluation of quality of life through focus groups, exploring physical, emotional/psychological, social, and economic impact of diabetic foot syndrome, as well as perceived benefits of the structured educational intervention.
This outcome is qualitative in nature and is not based on a numerical scale or score.
Measured: One assessment 30 days after study initiation, immediately following completion of the second educational intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María del Sol Tejeda Ramírez, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329491
- Sponsor's protocol ID
- 24/742-EC_X
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Structural Educational Intervention on the Prevention of Diabetic Foot Syndrome: A Ramdomized Clinical Trial Using a Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT07329491
- Acronym / sponsor ID
- 24/742-EC_X
- Keywords
- Diabetic foot, diabetic foot ulcer, health education, self care, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 9 Jan 2026 (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.
This randomized clinical trial assessed the impact of a structured educational intervention in patients with diabetic foot syndrome. Forty-two participants were allocated to an intervention group-receiving two specialist-led educational sessions-or to a control group with standard care.
The intervention produced significant improvements in knowledge and self-care after the first session, with stable retention and cumulative benefits by the end of the program. Clinically relevant improvements were also observed in skin condition and preventive foot-care behaviors such as appropriate footwear, socks, and nail-cutting technique.
Qualitative data showed that diabetes and DFS strongly affect quality of life, while group-based education enhanced peer support, sense of control, and adherence to preventive care. No ulcers occurred during the six-month follow-up.
Structured educational interventions are effective and rapidly beneficial, though larger studies with longer follow-up are needed to confirm their impact on ulcer prevention.
Detailed description
This randomized clinical trial evaluated the impact of a structured educational intervention on ulcer incidence, patient knowledge, self-care practices, and quality of life in individuals with diabetic foot syndrome (DFS). A total of 42 patients were assigned either to an intervention group-which received two monthly educational sessions delivered by a specialist-or to a control group receiving standard care.
The intervention followed IWGDF recommendations and covered topics such as DFS pathophysiology, glycemic control, ulcer risk identification, and evidence-based preventive strategies. Knowledge was assessed at four time points using a validated questionnaire. Self-care practices were assessed through clinical observation, and skin condition through the CERLCP scale. A qualitative analysis using focus groups explored patients' subjective experiences.
No new foot ulcers developed during the six-month follow-up. The intervention group demonstrated significant improvements in knowledge after the first session, with stable retention between sessions and cumulative gains by the end of the program. Marked improvements were also observed in self-care behaviors, particularly appropriate footwear and socks, nail-cutting technique, and reduction of hyperkeratosis. Skin quality improved with clinically meaningful effect sizes.
The qualitative findings showed that diabetes and DFS substantially affect patients' physical, emotional, social, and economic well-being. The educational intervention enhanced peer support, sense of control, and adherence to preventive self-care.
This study demonstrates that a structured educational intervention-even a single session-can produce rapid and meaningful improvements in knowledge and self-care practices. Larger studies with longer follow-up are required to determine its effectiveness in reducing ulcer incidence over time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured diabetic foot education program | Experimental | Behavioral: Structured education interventionParticipants attended two structured, group-based educational sessions on diabetic foot prevention based on IWGDF guidelines, delivered by a specialist, including foot self-care, footwear, and risk identification. |
| Standard podiatry care without structured education | Active comparator | Other: Standard podiatry careParticipants received standard care during routine chiropody consultations at a specialised unit, without additional structured educational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (≥18 years old) with a confirmed diagnosis of diabetes mellitus (Type
- 1 or Type 2).
- Classified at any risk level for diabetic foot ulceration according to the IWGDF Foot Risk Classification.
- Able to walk independently and capable of participating in educational activities and evaluations.
- Able to understand study procedures and voluntarily provide written informed consent.
Key exclusion criteria (5 listed)
- Decline to participate or inability to provide written informed consent.
- Presence of cognitive impairment, neurological disorders, or any condition that limits comprehension or adherence to study procedures.
- Severe physical or functional limitations preventing participation in foot assessments or educational sessions.
- Active diabetic foot ulcer or ongoing treatment for an acute foot wound at enrollment.
- Participation in another clinical trial that could interfere with study outcomes.
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 |
|---|---|---|
| Structured education interventionParticipants in the intervention arm received a structured educational program delivered face-to-face in small groups by a healthcare professional specialized in diabetic foot prevention. The program comprised two monthly sessions (2 hours each) following IWGDF recommendations. Session topics included diabetic foot pathophysiology, ulcer risk identification, glycaemic control, daily foot inspection, proper footwear and sock selection, nail care, skin care (hydration/creams) and recognition of warning signs. Teaching methods combined short lectures, visual materials, case examples and group discussion; participants received printed take-home guidance. Knowledge, self-care behaviours and foot skin condition were assessed pre/post intervention and participants were followed for 6 months to monitor outcomes. Structured diabetic foot education. | Behavioural | Structured diabetic foot education program |
| Standard podiatry careRoutine podiatry care provided during regular chiropody consultations at a specialised unit, including clinical foot assessment and usual advice, without any structured or formal educational program. | Other | Standard podiatry care without structured education |
Primary outcome
Incidence of new foot ulceration
Time frame: Baseline and 6-month follow-up
Proportion of participants developing a new diabetes-related foot ulcer (yes/no), defined as a full-thickness skin break on the foot. Assessed through clinical examination and medical record review during routine follow-up visits.
4 secondary outcomes
Knowledge score (6-item questionnaire)
Time frame: Baseline, immediately after the first educational session, 30 days later before the second session, and immediately after the second educational session.
Self-care behaviors (footwear, socks, toenail trimming, orthoses, maceration, hyperkeratosis)
Time frame: Baseline at the first educational session and immediately after the second educational session, 30 days later.
Sking quality. Questionnaire for the Evaluation of Injury Risk and Skin Quality in Diabetic Foot Sindrome (QERSQ).
Time frame: Baseline, immediately after the first educational intervention, and immediately after the second educational intervention at 30 days.
Quality of life related to diabetic foot syndrome (qualitative assessment)
Time frame: One assessment 30 days after study initiation, immediately following completion of the second educational intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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 Structured education intervention and Standard podiatry care in people with Diabetes Complications and Diabetes Education, run by Universidad Complutense de Madrid 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 new foot ulceration (time frame: Baseline and 6-month follow-up). 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 12 Jan 2026.