An interventional study of Intervention Group in Diabetic Foot Disease, sponsored by Anhui Medical University. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Anhui Medical University · Not applicable, Interventional, and Supportive care
Among 51 studies in Diabetic Foot with a site in China — 20 open to participants now, 23 under way, 1 of them phase 3. Diabetic Foot · China.
Among the 51 studies in Diabetic Foot with a site in China, this one is the 20th largest by planned enrollment of the 40 interventional ones that give a count, is one of 5 that started in 2026, is one of 15 with no phase, reaches primary completion later than 13 of the 22 other live ones, and was the 50th registered.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →20 of the 51 studies in Diabetic Foot with a site in China are open now.
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 7 · Phase 3 5 · Phase 4 6
First in 2000; this study’s year is marked. 5 started in 2026.
Median enrollment 70 across the 40 interventional studies, 200 across the 11 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.
4 of 51 have an industry lead sponsor. The 10 most frequent:
Anhui Medical University is the lead sponsor of 104 studies on the registry; 50 are open to participants now.
Anhui Medical University has 1 study filed under Diabetic Foot — fewer than ten, so there is no comparison to draw.
3 of the studies in Diabetic Foot with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07198061Shenyang Medical CollegeEfficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion | 2026-11-20 |
| NCT06309082First Affiliated Hospital of Wenzhou Medical UniversityAssessing Diabetic Foot Ulcer Microcirculation With High-frequency Contrast Enhanced Ultrasound | 2026-12 |
| NCT07482137Zhongda HospitalTherapeutic Effect of Electroacupuncture at Zusanli (ST-36) on Diabetic Foot Wounds | 2027-09-30 |
Among the 51 studies in Diabetic Foot with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(1) Meet the current Chinese criteria for older adults, aged ≥60 years;
(2) Clinically diagnosed with diabetic foot (DF);
(3) Voluntarily agree to participate in this study after being informed of the study purpose by the researcher.
Exclusion Criteria:
(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 (MMSE) indicating severe cognitive impairment;
(2) Severe communication impairment: patients unable to communicate normally with others due to hearing impairment, speech impairment, or other related conditions;
(3) Patients unable to complete the questionnaire survey for any reason;
(4) Patients currently participating in other trials that may affect the results of this study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Intervention Group
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.
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.
Time frame: From enrollment to the end of treatment at 5 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 5 weeks.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Oct 2026, 2 months later.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 2 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.