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A new care model asks: what matters most to people with diabetic foot ulcers?

NCT ID NCT07781111

Symptom relief Sponsor: Ulla Riis Madsen Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This study tests whether adding a proactive palliative care approach to routine diabetic foot ulcer care is feasible and acceptable. The model includes structured conversations to understand patients' concerns, priorities, and preferences for care, with relatives involved when appropriate. Researchers will gather feedback from patients, relatives, and healthcare professionals to see if this approach fits into daily practice and supports better care.

What this could mean

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

Active substance
A proactive palliative care model that includes structured conversations about patients' health concerns, priorities, and care preferences.
What this could lead to
If successful, this approach could improve quality of life and align care with what matters most to people with diabetic foot ulcers.
What could go wrong
This is a small feasibility study, so it may not show clear benefits. It also depends on how well clinicians and patients accept the conversations.

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.

Participants

About 484 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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.

Who is studied

The study population comprises adult patients with diabetic foot ulcers (DFU) receiving care at two participating outpatient wound clinics, their relatives or close persons where applicable, and healthcare professionals involved in DFU care and in the implementation and delivery of the ProActive model. For Studies 1-3, patient participants are those who are offered and participate in a Status Conversation as part of the ProActive model. Study 4 includes the broader population of all adult patients with DFU who are newly referred to the participating clinics during the 12-month test phase or who develop a new or recurrent DFU during ongoing follow-up, regardless of whether they are offered or participate in a Status Conversation.

Ages

18 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.

Study 1-3: Inclusion Criteria: Health professionals: \- Healthcare professionals involved in DFU care and in the implementation and delivery of the ProActive model at one of the participating sites, including specialized wound care nurses and vascular or orthopaedic surgeons. Patient and relatives * Aged ≥18 years. * Have a diabetic foot ulcer (DFU). * Receive care at one of the two participating outpatient wound clinics. * Are offered and participate in a Status Conversation as part of the ProActive model in routine clinical practice. * Are able to provide informed consent. Exclusion Criteria: Healthcare professionals: -Not involved in DFU care or in the implementation or delivery of the ProActive model at the participating sites. Patients and relatives: * Unable to provide informed consent. * Do not otherwise meet the relevant inclusion criteria. Study 4: Inclusion Criteria: * Aged ≥18 years. * Have a diabetic foot ulcer (DFU). * Are newly referred to one of the participating outpatient wound clinics during the 12-month test phase, or develop a new or recurrent DFU during ongoing follow-up at one of the participating clinics. * Included regardless of whether they are identified as potentially relevant for, offered, or participate in a Status Conversation. Exclusion Criteria: * Patients who are not newly referred during the test phase and who do not develop a new or recurrent DFU during ongoing follow-up at one of the participating clinics. * Patients with insufficient Danish language skills to understand questionnaires or study instructions, or with cognitive impairment that prevents understanding of instructions or participation in a Status Conversation.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

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

Advance care planning Diabetic foot ulcer (DFU) Palliative care

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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