Diabetic Foot DiseaseNCT07787884
Development and Pilot Application of a Solution-Focused Intervention for Social Isolation in Elderly Diabetic Foot Patients
A study testing Intervention Group in people with Diabetic Foot Disease, run by Anhui Medical University at 1 site in China.
Trial summary
The goal of this interventional study is to develop and preliminarily evaluate a solution-focused model-based intervention program for reducing social isolation in elderly patients with diabetic foot ulcers. It will also learn about the feasibility and safety of the intervention program. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetic Foot Disease
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Meet the current Chinese criteria for older adults, aged ≥60 years;
- Clinically diagnosed with diabetic foot (DF);
- Voluntarily agree to participate in this study after being informed of the study purpose by the researcher.
Who cannot join
- (1) Severe cognitive impairment or mental disorders: patients definitively diagnosed with Parkinson's disease, senile dementia, or severe depression by a Class II-A or higher hospital; or those with a score below 9 on the Mini-Mental State Examination (MMSE) indicating severe cognitive impairment;
- Severe communication impairment: patients unable to communicate normally with others due to hearing impairment, speech impairment, or other related conditions;
- Patients unable to complete the questionnaire survey for any reason;
- Patients currently participating in other trials that may affect the results of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230031
Junnan Song, +86 18712096043, junnansong00@163.com
junnansong00@163.com
About this study
Official title: Construction and Preliminary Application of a Solution-Focused Model-Based Intervention Program for Social Isolation in Elderly Patients With Diabetic Foot Ulcers
The goal of this interventional study is to develop and preliminarily evaluate a solution-focused model-based intervention program for reducing social isolation in elderly patients with diabetic foot ulcers. It will also learn about the feasibility and safety of the intervention program. The main questions it aims to answer are:
Does the solution-focused intervention program effectively reduce social isolation levels in elderly patients with diabetic foot ulcers?
Read more
What effects does the intervention have on patients' foot self-care behaviors, social participation, social support, depressive symptoms, and glycemic control?
Researchers will compare an intervention group (receiving the solution-focused intervention combined with routine nursing care) to a control group (receiving routine nursing care only) to see if the intervention program works to alleviate social isolation in this population.
Participants will:
Complete a set of validated questionnaires (including assessments of social isolation, foot self-care behaviors, social support, social participation, and depressive symptoms) and undergo fasting blood glucose measurement at four time points: baseline, after 3 intervention sessions, at intervention completion, and 1-month post-intervention
Attend 5 weekly sessions (0.5 -1 hours each) of the solution-focused intervention program, which follows five core steps: problem description, goal setting, exception exploration, feedback, and progress evaluation (intervention group only)
Receive routine nursing care including blood glucose monitoring, dietary management, medication guidance, psychological support, and activity instructions (both groups)
- Conditions
- Diabetic Foot Disease
- Being tested
- Intervention Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Researchers will compare an intervention group (receiving the solution-focused intervention plus routine care) to a control group (receiving routine care only).
Participants will complete validated questionnaires (LSNS-6, NAFF, SSRS, IPA, CES-D-10) and undergo fasting blood glucose measurement at four time points: baseline, after 3 sessions, at intervention completion, and 1-month post-intervention. The intervention group will attend 5 weekly sessions (1-1.5 hours each) following five core steps: problem description, goal setting, exception exploration, feedback, and progress evaluation. Both groups receive routine care including blood glucose monitoring, dietary management, medication guidance, psychological support, and activity instructions.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Intervention Group | Other | Not described Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Social Isolation
Measured by the Lubben Social Network Scale-6 (LSNS-6) , an abbreviated version of the original Lubben Social Network Scale developed by Lubben et al. The LSNS-6 assesses social network status from two dimensions: family network (3 items) and friend network (3 items), totaling 6 items. Each item is rated on a 6-point Likert scale (0 = none, 1 = one, 2 = two, 3 = three to four, 4 = five to eight, 5 = nine or more). Total scores range from 0 to 30. A total score <12 indicates social isolation. Family network score <6 indicates family network isolation, and friend network score <6 indicates friend network isolation. The Chinese version has demonstrated adequate internal consistency with a Cronbach's α of 0.832.
Measured: From enrollment to the end of treatment at 5 weeks
Secondary outcomes (5)
Social support level
Social support level measured by the Medical Outcomes Study Social Support Survey (MOS-SSS). The MOS-SSS contains 19 items across four dimensions: emotional/informational support (8 items), tangible support (4 items), affectionate support (3 items), and positive social interaction (4 items). Each item is rated on a 5-point Likert scale (1=none of the time, 5=all of the time). Total scores are transformed to a 0-100 scale, with higher scores indicating better social support. The Chinese version has demonstrated good reliability and validity, with a Cronbach's α of 0.91.
Measured: From enrollment to the end of treatment at 5 weeks.
Social participation level
Social participation level measured by the Social Participation Scale. This scale assesses the frequency and diversity of social activities across multiple domains, including family interactions, community activities, and social gatherings. Each item is rated on a 5-point Likert scale (1=never, 5=very often). Higher total scores indicate a higher level of social participation. The scale has been validated in older adult populations with chronic diseases, demonstrating satisfactory psychometric properties with a Cronbach's α of 0.85.
Measured: From enrollment to the end of treatment at 5 weeks.
Depressive symptoms
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items corresponding to the DSM-IV diagnostic criteria for major depressive disorder. Each item is rated on a 4-point Likert scale (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day) based on symptom frequency over the past two weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms (0-5 minimal, 6-10 mild, 11-15 moderate, 16-20 moderately severe, 21-27 severe). Cronbach's α=0.89.
Measured: From enrollment to the end of treatment at 5 weeks.
Glycemic control (fasting blood glucose)
Glycemic control measured by fasting blood glucose (FBG) in millimoles per liter (mmol/L). Venous blood samples are collected after an 8-hour overnight fast and analyzed using the standardized glucose oxidase method. Lower FBG values indicate better glycemic control. According to the Chinese Diabetes Society guidelines, normal FBG is 3.9-6.1 mmol/L. This objective biomarker provides a reliable assessment of short-term glycemic status.
Measured: From enrollment to the end of treatment at 5 weeks.
Diabetic foot self-care behaviors
Diabetic foot self-care behaviors measured by the Diabetic Foot Self-Care Behavior Scale. This scale evaluates patients' adherence to recommended foot care practices, including daily foot inspection, proper washing and drying, moisturizing, nail care, appropriate footwear selection, and avoiding barefoot walking. Items are rated on a 5-point Likert scale (1=never, 5=always). Higher total scores indicate better adherence to diabetic foot self-care behaviors. The scale has shown good reliability with a Cronbach's α of 0.88.
Measured: From enrollment to the end of treatment at 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start27 Aug 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot DiseaseStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Junnan, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787884
- Sponsor's protocol ID
- 81250948
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Preliminary Application of a Solution-Focused Model-Based Intervention Program for Social Isolation in Elderly Patients With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07787884
- Acronym / sponsor ID
- 81250948
- Conditions
- Diabetic Foot Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 27 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 26 Aug 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.
The goal of this interventional study is to develop and preliminarily evaluate a solution-focused model-based intervention program for reducing social isolation in elderly patients with diabetic foot ulcers. It will also learn about the feasibility and safety of the intervention program. The main questions it aims to answer are:
Does the solution-focused intervention program effectively reduce social isolation levels in elderly patients with diabetic foot ulcers?
What effects does the intervention have on patients' foot self-care behaviors, social participation, social support, depressive symptoms, and glycemic control?
Researchers will compare an intervention group (receiving the solution-focused intervention combined with routine nursing care) to a control group (receiving routine nursing care only) to see if the intervention program works to alleviate social isolation in this population.
Participants will:
Complete a set of validated questionnaires (including assessments of social isolation, foot self-care behaviors, social support, social participation, and depressive symptoms) and undergo fasting blood glucose measurement at four time points: baseline, after 3 intervention sessions, at intervention completion, and 1-month post-intervention
Attend 5 weekly sessions (0.5 -1 hours each) of the solution-focused intervention program, which follows five core steps: problem description, goal setting, exception exploration, feedback, and progress evaluation (intervention group only)
Receive routine nursing care including blood glucose monitoring, dietary management, medication guidance, psychological support, and activity instructions (both groups)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Intervention Group | Other | Other: Intervention Group |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) Meet the current Chinese criteria for older adults, aged ≥60 years;
Key exclusion criteria (4 listed)
- (1) Severe cognitive impairment or mental disorders: patients definitively diagnosed with Parkinson's disease, senile dementia, or severe depression by a Class II-A or higher hospital; or those with a score below 9 on the Mini-Mental State Examination (MMSE) indicating severe cognitive impairment;
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 |
|---|---|---|
| Intervention GroupResearchers will compare an intervention group (receiving the solution-focused intervention plus routine care) to a control group (receiving routine care only). Participants will complete validated questionnaires (LSNS-6, NAFF, SSRS, IPA, CES-D-10) and undergo fasting blood glucose measurement at four time points: baseline, after 3 sessions, at intervention completion, and 1-month post-intervention. The intervention group will attend 5 weekly sessions (1-1.5 hours each) following five core steps: problem description, goal setting, exception exploration, feedback, and progress evaluation. Both groups receive routine care including blood glucose monitoring, dietary management, medication guidance, psychological support, and activity instructions. | Other | Intervention Group |
Primary outcome
Level of Social Isolation
Time frame: From enrollment to the end of treatment at 5 weeks
Measured by the Lubben Social Network Scale-6 (LSNS-6) , an abbreviated version of the original Lubben Social Network Scale developed by Lubben et al. The LSNS-6 assesses social network status from two dimensions: family network (3 items) and friend network (3 items), totaling 6 items. Each item is rated on a 6-point Likert scale (0 = none, 1 = one, 2 = two, 3 = three to four, 4 = five to eight, 5 = nine or more). Total scores range from 0 to 30. A total score <12 indicates social isolation. Family network score <6 indicates family network isolation, and friend network score <6 indicates friend network isolation. The Chinese version has demonstrated adequate internal consistency with a Cronbach's α of 0.832.
5 secondary outcomes
Social support level
Time frame: From enrollment to the end of treatment at 5 weeks.
Social participation level
Time frame: From enrollment to the end of treatment at 5 weeks.
Depressive symptoms
Time frame: From enrollment to the end of treatment at 5 weeks.
Glycemic control (fasting blood glucose)
Time frame: From enrollment to the end of treatment at 5 weeks.
Diabetic foot self-care behaviors
Time frame: From enrollment to the end of treatment at 5 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Diabetic Foot Disease, run by Anhui Medical University at 1 site in China.
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 3 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: opening soon, as of the sponsor's last update on 26 Aug 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junnan Song (+86 18712096043, junnansong00@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Social Isolation (time frame: From enrollment to the end of treatment at 5 weeks). 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 Aug 2026.