Primary Health CareNCT06250049
Improvement of Diabetic Foot Care in Salamanca Through the Implementation of Standardized Protocols.
A study testing Diabetic foot care protocol and Group education sessions for patients and/or caregivers in people with Primary Health Care and Diabetes, run by Sanidad de Castilla y León at 1 site in Spain.
Trial summary
Introduction: Diabetic foot (DF) is among the most prevalent complications affecting individuals with diabetes. In Salamanca, 25,631 individuals are enrolled in the Diabetes Care Service, with only 3.06% undergoing a foot examination. Read more about this study
- Who is it for?
- Ages 14 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Health Care, Diabetes, Diabetic Foot
- What is being tested?
- Diabetic foot care protocol and Group education sessions for patients and/or caregivers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25,631 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 1 Nov 2023
- 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 14 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals included in the "Care for individuals with DM" Service of the Primary Care Services Portfolio of SACYL, aged 14 years and older.
Who cannot join
- Change of patient's residence to another Health Area.
- Patient who voluntarily declines to be included.
- Patients with amputation of both lower limbs.
- Patient's decease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Implementation of a Standardized Foot Care Protocol in Individuals With Diabetes in Primary Care in Salamanca
Introduction: Diabetic foot (DF) is among the most prevalent complications affecting individuals with diabetes. In Salamanca, 25,631 individuals are enrolled in the Diabetes Care Service, with only 3.06% undergoing a foot examination.
Objective: To evaluate the effectiveness of implementing a standardized foot care protocol for individuals with diabetes, accompanied by a sensitization and training strategy for nursing professionals.
Read more
Methodology: Quasi-experimental pre- and post-study with a control group conducted in the Health Centers of Salamanca.
Population: Patients included in the Diabetes Care Service (306) (12,458 men and 11,348 women).
Measurements:
In professionals: number of professionals involved and satisfaction level. In diabetic individuals: Sociodemographic, anthropometric, lifestyle, and clinical variables related to disease control will be measured, along with variables related to protocol implementation (percentage of diabetics who have undergone foot examination, Ankle-Brachial Index (ABI), risk stratification and foot monitoring, percentage of individuals with DF, percentage of individuals with healed DF ulcers, and percentage of individuals who have undergone amputation). Improvement in quality of life will be measured using the COOP-WONCA questionnaire.
Expected outcomes: It is anticipated that this study will provide evidence regarding the relationship between protocol implementation and an increase in the detection and care of at-risk feet and DF, as well as an improvement in the quality of life of individuals with diabetes.
Read the detailed description
The diabetic foot (DF) is a common complication in individuals with DM, significantly increasing morbidity and mortality. Patients with DM face a 10-20 times higher relative risk of lower limb amputation than those without diabetes, primarily due to ulcers or previous injuries associated with neuropathy and peripheral arterial disease, termed DF (WHO, 2020). Short-to-medium-term mortality post-amputation is comparable to, or even higher than, many cancers (Armstrong et al., 2020).
Diabetic foot disease (DFD) causes significant patient suffering and imposes a substantial burden on caregivers, healthcare professionals, health services, and society at large (Schaper et al., 2020). Despite its impact, DFD is often underestimated and underdiagnosed, as healthcare professionals perceive its prevalence and clinical, social, and economic consequences inadequately (Suárez and Lozano, 2014). In Spain, DF screening and risk stratification are systematically conducted in Primary Care (PC), but overall data show a low percentage of DF examinations and record-keeping in medical records, with significant variations among autonomous communities, potentially influenced by the implementation of strategies addressing this complication (Ministry of Health, 2022).
To address existing barriers hindering more equitable and high-quality care for DF patients within the National Health System (NHS), the document "Diabetic Foot Management" is developed as part of the Diabetes Strategy (Ministry of Health, 2022). Based on the International Working Group on the Diabetic Foot (IWGDF) consensus, it incorporates key recommendations from various guidelines regarding educational aspects (for patients, caregivers, and professionals), DF screening, and interventions to reduce amputations and enhance the quality of life. It emphasizes that DF management should primarily occur in Primary Care, adopting a multidisciplinary approach (Ministry of Health, 2022).
- Conditions
- Primary Health Care, Diabetes, Diabetic Foot
- Being tested
- Diabetic foot care protocol, Group education sessions for patients and/or caregivers
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic foot care protocolOther
Introduction of the diabetic foot care protocol in Primary Care in Salamanca, sensitization, and training of nursing professionals in Health Centers (HC).
Group education sessions for patients and/or caregiversOther
Conducting group education sessions for patients and/or caregivers on Diabetic Foot Care at the Health Centers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group of patients will be attended according to a diabetic foot care protocol implemented in Primary Care in Salamanca. In addition, those patients and/or caregivers will receive group education sessions on Diabetic Foot Care at the Health Centers. Receives: Other: Diabetic foot care protocol; Other: Group education sessions for patients and/or caregivers |
| Control Group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of individuals with diabetes mellitus who have undergone examination and exploration of both feet
Number of individuals with diabetes mellitus who have undergone examination and exploration of both feet.
Measured: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes who have undergone foot risk stratification.
Number of individuals with diabetes who have undergone foot risk stratification.
Measured: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes who have received group education related to diabetic foot care.
Number of individuals with diabetes who have received group education related to diabetic foot care.
Measured: Pre (baseline period) and Post-intervention (6-month)
Quality of life of individuals with diabetes
Quality of life of individuals with diabetes pre and post intervention measured through the COOP-WONCA questionnaire. The COOP/WONCA questionnaire was originally developed by a group of primary care physicians at The Darmouth Primary Care Cooperative Information Project (COOP Project), Hanover, New Hampsshire USA. The questionnaire consists of 9 items with a 5-point Likert-type scale. , where higher scores express worse levels of functioning. It was in 1988 when the World Organization of National Colleges, Academies, and Academic Associations of General Practitioners/Family Physicians (WONCA) adopted this instrument.
Measured: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes with a nursing care plan established.
Number of individuals with diabetes with a nursing care plan established.
Measured: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes who have received individual education related to diabetic foot care.
Number of individuals with diabetes who have received individual education related to diabetic foot care.
Measured: Pre (baseline period) and Post-intervention (6-month)
Secondary outcomes (8)
Number of Primary Care teams where the sensitization and training strategy has been implemented.
Number of Primary Care teams where the sensitization and training strategy has been implemented.
Measured: Post-intervention (6-month)
Satisfaction level of professionals regarding sensitization and training
Satisfaction level of professionals regarding sensitization and training through an ad hoc questionnaire carried out by the Ministry of Health of the Government of Castilla y León (SACYL) with a Likert-type scale.
Measured: Post-intervention (6-month)
Percentage of professionals who have implemented the protocol after training.
Percentage of professionals who have implemented the protocol after training.
Measured: Pre (baseline period) and Post-intervention (6-month)
Number of individuals detected with at-risk feet.
Number of individuals detected with at-risk feet.
Measured: Pre (baseline period) and Post-intervention (6-month)
Number of individuals detected with diabetic foot.
Number of individuals detected with diabetic foot.
Measured: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes with diabetic foot ulcers who have achieved healing (at least one) in the last year.
Number of individuals with diabetes with diabetic foot ulcers who have achieved healing (at least one) in the last year.
Measured: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes who have undergone lower limb amputation (partial or total) in the last year.
Number of individuals with diabetes who have undergone lower limb amputation (partial or total) in the last year.
Measured: Pre (baseline period) and Post-intervention (6-month)
Number of diabetic individuals referred to podiatry, vascular surgery, and traumatology and orthopedics.
Number of diabetic individuals referred to podiatry, vascular surgery, and traumatology and orthopedics.
Measured: Pre (baseline period) and Post-intervention (6-month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Mar 2023
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Health CareStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 25,631 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanidad de Castilla y León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Manzano Garcia, Sanidad de Castilla y León
- Investigators
- Marta Manzano García, Principal investigator, Sanidad de Castilla y León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250049
- Sponsor's protocol ID
- GRS/2534/B/22
- Status last verified
- May 2025
- First submitted
- 12 Jan 2024
- Last updated
- 28 May 2025
- Results posted
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Implementation of a Standardized Foot Care Protocol in Individuals With Diabetes in Primary Care in Salamanca
- ClinicalTrials.gov ID
- NCT06250049
- Acronym / sponsor ID
- GRS/2534/B/22
- Conditions
- Primary Health Care, Diabetes, Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25,631 participants (actual)
- Lead sponsor
- Sanidad de Castilla y LeónUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 8 Feb 2024 (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.
Introduction: Diabetic foot (DF) is among the most prevalent complications affecting individuals with diabetes. In Salamanca, 25,631 individuals are enrolled in the Diabetes Care Service, with only 3.06% undergoing a foot examination.
Objective: To evaluate the effectiveness of implementing a standardized foot care protocol for individuals with diabetes, accompanied by a sensitization and training strategy for nursing professionals.
Methodology: Quasi-experimental pre- and post-study with a control group conducted in the Health Centers of Salamanca.
Population: Patients included in the Diabetes Care Service (306) (12,458 men and 11,348 women).
Measurements:
In professionals: number of professionals involved and satisfaction level. In diabetic individuals: Sociodemographic, anthropometric, lifestyle, and clinical variables related to disease control will be measured, along with variables related to protocol implementation (percentage of diabetics who have undergone foot examination, Ankle-Brachial Index (ABI), risk stratification and foot monitoring, percentage of individuals with DF, percentage of individuals with healed DF ulcers, and percentage of individuals who have undergone amputation). Improvement in quality of life will be measured using the COOP-WONCA questionnaire.
Expected outcomes: It is anticipated that this study will provide evidence regarding the relationship between protocol implementation and an increase in the detection and care of at-risk feet and DF, as well as an improvement in the quality of life of individuals with diabetes.
Detailed description
The diabetic foot (DF) is a common complication in individuals with DM, significantly increasing morbidity and mortality. Patients with DM face a 10-20 times higher relative risk of lower limb amputation than those without diabetes, primarily due to ulcers or previous injuries associated with neuropathy and peripheral arterial disease, termed DF (WHO, 2020). Short-to-medium-term mortality post-amputation is comparable to, or even higher than, many cancers (Armstrong et al., 2020).
Diabetic foot disease (DFD) causes significant patient suffering and imposes a substantial burden on caregivers, healthcare professionals, health services, and society at large (Schaper et al., 2020). Despite its impact, DFD is often underestimated and underdiagnosed, as healthcare professionals perceive its prevalence and clinical, social, and economic consequences inadequately (Suárez and Lozano, 2014). In Spain, DF screening and risk stratification are systematically conducted in Primary Care (PC), but overall data show a low percentage of DF examinations and record-keeping in medical records, with significant variations among autonomous communities, potentially influenced by the implementation of strategies addressing this complication (Ministry of Health, 2022).
To address existing barriers hindering more equitable and high-quality care for DF patients within the National Health System (NHS), the document "Diabetic Foot Management" is developed as part of the Diabetes Strategy (Ministry of Health, 2022). Based on the International Working Group on the Diabetic Foot (IWGDF) consensus, it incorporates key recommendations from various guidelines regarding educational aspects (for patients, caregivers, and professionals), DF screening, and interventions to reduce amputations and enhance the quality of life. It emphasizes that DF management should primarily occur in Primary Care, adopting a multidisciplinary approach (Ministry of Health, 2022).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Diabetic foot care protocol, Other: Group education sessions for patients and/or caregiversThis group of patients will be attended according to a diabetic foot care protocol implemented in Primary Care in Salamanca. In addition, those patients and/or caregivers will receive group education sessions on Diabetic Foot Care at the Health Centers. |
| Control Group | No intervention | –Usual care |
Who may qualify
- Ages
- 14 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals included in the "Care for individuals with DM" Service of the Primary Care Services Portfolio of SACYL, aged 14 years and older.
Key exclusion criteria (4 listed)
- Change of patient's residence to another Health Area.
- Patient who voluntarily declines to be included.
- Patients with amputation of both lower limbs.
- Patient's decease.
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 |
|---|---|---|
| Diabetic foot care protocolIntroduction of the diabetic foot care protocol in Primary Care in Salamanca, sensitization, and training of nursing professionals in Health Centers (HC). | Other | Intervention Group |
| Group education sessions for patients and/or caregiversConducting group education sessions for patients and/or caregivers on Diabetic Foot Care at the Health Centers. | Other | Intervention Group |
Primary outcome
Percentage of individuals with diabetes mellitus who have undergone examination and exploration of both feet
Time frame: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes mellitus who have undergone examination and exploration of both feet.
Number of individuals with diabetes who have undergone foot risk stratification.
Time frame: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes who have undergone foot risk stratification.
Number of individuals with diabetes who have received group education related to diabetic foot care.
Time frame: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes who have received group education related to diabetic foot care.
Quality of life of individuals with diabetes
Time frame: Pre (baseline period) and Post-intervention (6-month)
Quality of life of individuals with diabetes pre and post intervention measured through the COOP-WONCA questionnaire. The COOP/WONCA questionnaire was originally developed by a group of primary care physicians at The Darmouth Primary Care Cooperative Information Project (COOP Project), Hanover, New Hampsshire USA. The questionnaire consists of 9 items with a 5-point Likert-type scale. , where higher scores express worse levels of functioning. It was in 1988 when the World Organization of National Colleges, Academies, and Academic Associations of General Practitioners/Family Physicians (WONCA) adopted this instrument.
Number of individuals with diabetes with a nursing care plan established.
Time frame: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes with a nursing care plan established.
Number of individuals with diabetes who have received individual education related to diabetic foot care.
Time frame: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes who have received individual education related to diabetic foot care.
8 secondary outcomes
Number of Primary Care teams where the sensitization and training strategy has been implemented.
Time frame: Post-intervention (6-month)
Satisfaction level of professionals regarding sensitization and training
Time frame: Post-intervention (6-month)
Percentage of professionals who have implemented the protocol after training.
Time frame: Pre (baseline period) and Post-intervention (6-month)
Number of individuals detected with at-risk feet.
Time frame: Pre (baseline period) and Post-intervention (6-month)
Number of individuals detected with diabetic foot.
Time frame: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes with diabetic foot ulcers who have achieved healing (at least one) in the last year.
Time frame: Pre (baseline period) and Post-intervention (6-month)
Number of individuals with diabetes who have undergone lower limb amputation (partial or total) in the last year.
Time frame: Pre (baseline period) and Post-intervention (6-month)
Number of diabetic individuals referred to podiatry, vascular surgery, and traumatology and orthopedics.
Time frame: Pre (baseline period) and Post-intervention (6-month)
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 28 May 2025.
- 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.
Marta Manzano García principal investigator
Sanidad de Castilla y León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetic foot care protocol and Group education sessions for patients and/or caregivers in people with Primary Health Care and Diabetes, run by Sanidad de Castilla y León 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 1 inclusion and 4 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 28 May 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 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?
Percentage of individuals with diabetes mellitus who have undergone examination and exploration of both feet (time frame: Pre (baseline period) and Post-intervention (6-month)). The study lists 6 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 28 May 2025.