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Can a 5-Week talk program break the isolation of diabetic foot ulcers?

NCT ID NCT07787884

Symptom relief Sponsor: Anhui Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study tests whether a structured, solution-focused counseling program can reduce social isolation in older adults with diabetic foot ulcers. Participants will attend five weekly sessions focused on goal-setting and problem-solving, alongside routine care, and will be compared to a group receiving only routine care. The trial measures changes in social isolation, foot self-care, social support, mood, and blood sugar levels over several weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Solution-focused model-based intervention program (behavioral intervention)
What this could lead to
If effective, this program could offer a simple, non-drug way to reduce loneliness and improve self-care and blood sugar control in older adults with diabetic foot ulcers.
What could go wrong
This is a small, early-stage study with only 70 participants, so results may not apply broadly. The intervention's success depends on patient engagement and may not overcome severe social or medical challenges.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * (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 Mini-Mental State Examination (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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot disease

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230031, China

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