Diabetic Foot Ulcer (DFU)NCT07781111
The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care
An observational study of Diabetic Foot Ulcer (DFU) and Palliative Care, run by Ulla Riis Madsen.
Trial summary
The ProActive study aims to investigate the feasibility of integrating a proactive palliative care approach into routine care for people with diabetic foot ulcers (DFU). The ProActive model includes procedures to identify patients who may benefit from a palliative approach and structured serious illness conversations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Palliative Care, Advance Care Planning
- How many people
- 484 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 28 Feb 2029
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Show all 12Show fewer
- Are offered and participate in a Status Conversation as part of the ProActive model in routine clinical practice.
- Are able to provide informed consent.
- 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.
Who cannot join
- 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:
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care. A Feasibility Study.
The ProActive study aims to investigate the feasibility of integrating a proactive palliative care approach into routine care for people with diabetic foot ulcers (DFU).
The ProActive model includes procedures to identify patients who may benefit from a palliative approach and structured serious illness conversations (SIC) addressing patients' health situation, concerns, priorities, and preferences for care. Relatives may be involved when appropriate.
Read more
The study examines the feasibility, acceptability, and appropriateness of the ProActive model and its implementation from the perspectives of patients, relatives, and healthcare professionals. It also evaluates the feasibility of outcome measures and data collection procedures for a future effectiveness study and examines the procedures used to identify patients who may benefit from the intervention.
The feasibility study is conducted at two DFU clinics in Denmark and consists of four complementary sub-studies using qualitative and quantitative methods.
Read the detailed description
People with diabetic foot ulcers (DFU) may live with substantial symptom burden, impaired quality of life, uncertainty, and complex care needs. Despite the serious health consequences associated with DFU, a palliative approach is not routinely integrated into DFU care. The ProActive study therefore investigates the feasibility of integrating a proactive palliative care approach into routine DFU care.
The ProActive model includes systematic procedures for identifying patients who may benefit from a palliative approach and structured serious illness conversations (SIC). The conversations provide an opportunity to discuss the patient's understanding of their health situation, concerns, priorities, and preferences for future care. Relatives may participate when appropriate.
Healthcare professionals at the participating DFU clinics receive training and support to deliver the intervention and integrate it into existing clinical practice. The implementation process is informed by the Medical Research Council framework for developing and evaluating complex interventions, with particular attention to context, stakeholder involvement, and uncertainties related to feasibility.
Study 1 investigates the feasibility of the ProActive model and its implementation from the perspective of healthcare professionals. Data are collected through observations during implementation activities and focus group interviews with healthcare professionals (N=14). Particular attention is given to the acceptability, appropriateness, and feasibility of the intervention and its implementation in routine DFU care.
Study 2 explores patients' and relatives' experiences of the ProActive model and SIC. Patients participating in the intervention, and relatives when applicable, are invited to qualitative interviews exploring their experiences of the conversation and the relevance and acceptability of introducing a proactive palliative approach in DFU care. The study includes up to 20 patients and their relatives.
Study 3 evaluates the feasibility of outcome measures and data collection procedures intended for use in a future effectiveness evaluation. Patient-, relative-, and healthcare professional-reported measures are collected to assess completion, timing, participant burden, and the suitability of the selected measures and procedures. The study includes up to 50 patients and their relatives where applicable, and 14 healthcare professionals.
Study 4 evaluates the procedures used to identify and recruit patients who may benefit from the ProActive model. All patients with DFU referred to the participating clinics during the 12-month test phase (N=400) are included in a retrospective assessment of identification and recruitment procedures and selected clinical outcomes.
Findings from the four sub-studies will be integrated to assess the overall feasibility of the ProActive model and its implementation and to identify refinements needed before a future evaluation of effectiveness.
- Keywords
- ProActive, serious illness conversations, palliative care, diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Health care professionals | Healthcare professionals involved in the care of patients with diabetic foot ulcers (DFU) at the participating clinics. Healthcare professionals will take part in the structured implementation activities, including workshops and communication training, and will subsequently deliver the ProActive intervention, including adapted serious illness conversations (SIC), as part of routine DFU care. | |
| Patients and relatives- interview | Patients with diabetic foot ulcers (DFU) receiving care at the participating clinics and, where applicable, their relatives. Patients will receive the ProActive intervention, including an adapted serious illness conversation (SIC) as part of routine DFU care. Patients and relatives will subsequently be invited to participate in interviews exploring their experiences of the ProActive intervention, including the SIC and the proactive palliative care approach. | |
| Patients and relatives- questionaires | Patients with diabetic foot ulcers (DFU) receiving care at the participating clinics and, where applicable, their relatives. Participants will complete questionnaires to assess the feasibility of selected outcome measures and data collection procedures for a future effectiveness evaluation of the ProActive intervention. Patients will complete questionnaires before the intervention and at 1 and 3 months after the intervention, while relatives will complete a questionnaire according to the study procedures. | |
| Patients - retrospective clinical data | All patients with diabetic foot ulcers (DFU) referred to the participating clinics during the 12-month test phase. Routinely collected clinical data will be used retrospectively to assess the feasibility of the patient identification and recruitment procedures and to describe relevant clinical outcomes during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the ProActive model assessed by AIM
Acceptability of the ProActive model will be assessed among clinicians using the Acceptability of Intervention Measure (AIM). AIM consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater perceived acceptability.
Measured: After the 3-month test phase
Feasibility of the ProActive model assessed by FIM
Feasibility of the ProActive model will be assessed among clinicians using the Feasibility of Intervention Measure (FIM). FIM consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater perceived feasibility.
Measured: After the 3-month test phase
Appropriateness of the ProActive model assessed by IAM
Appropriateness of the ProActive model will be assessed among clinicians using the Intervention Appropriateness Measure (IAM). IAM consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater perceived appropriateness.
Measured: After the 3-month test phase
Clinician experiences of ProActive implementation assessed by focus group interviews
Clinicians' experiences of implementing ProActive in routine diabetic foot ulcer care will be explored through post-intervention focus group interviews. Interviews will address implementation, local adaptation, interdisciplinary collaboration, barriers and facilitators, and integration into routine clinical practice.
Measured: After the 3-month test phase
Patient and relative experiences of Status Conversations assessed by interviews
Patient and relative experiences of ProActive will be explored through semi-structured interviews after participation in a Status Conversation. Interviews will address experiences of being met with a proactive palliative care approach, perceived relevance and timing of the Status Conversation, preparation, emotional impact, involvement of relatives, and perceived benefits and challenges.
Measured: Approximately 3 weeks after the Status Conversation
Feasibility of patient-reported questionnaire completion
Feasibility of patient-reported questionnaire completion will be assessed descriptively using response rates, completeness of questionnaire data, missing data, and timing of completion for patient-reported questionnaires.
Measured: Baseline, 1 month, and 3 months after the Status Conversation
Feasibility of identification procedures for Status Conversations
Feasibility of identification procedures will be assessed descriptively using the proportion of eligible patients assessed for potential relevance for a Status Conversation, identified as potentially relevant, offered a Status Conversation, and accepting or declining the conversation.
Measured: During the 12-month test phase, with retrospective assessment after 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulla Riis Madsen
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus, REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Steno Diabetes Center Copenhagen, Steno Diabetes Center Sjaelland, Independent Research Fund Denmark, Odense Patient Data Explorative Network
- Responsible party
- Sponsor-investigator, Ulla Riis Madsen, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781111
- Sponsor's protocol ID
- EMN-2026-04148
- Other IDs
- 5333-00033B
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care. A Feasibility Study.
- ClinicalTrials.gov ID
- NCT07781111
- Acronym / sponsor ID
- EMN-2026-04148
- Keywords
- ProActive, serious illness conversations, palliative care, diabetic foot ulcer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Ulla Riis MadsenUniversity, hospital or other
- Collaborators
- Kolding Sygehus, REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Steno Diabetes Center Copenhagen, Steno Diabetes Center Sjaelland, Independent Research Fund Denmark, Odense Patient Data Explorative Network
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 24 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 ProActive study aims to investigate the feasibility of integrating a proactive palliative care approach into routine care for people with diabetic foot ulcers (DFU).
The ProActive model includes procedures to identify patients who may benefit from a palliative approach and structured serious illness conversations (SIC) addressing patients' health situation, concerns, priorities, and preferences for care. Relatives may be involved when appropriate.
The study examines the feasibility, acceptability, and appropriateness of the ProActive model and its implementation from the perspectives of patients, relatives, and healthcare professionals. It also evaluates the feasibility of outcome measures and data collection procedures for a future effectiveness study and examines the procedures used to identify patients who may benefit from the intervention.
The feasibility study is conducted at two DFU clinics in Denmark and consists of four complementary sub-studies using qualitative and quantitative methods.
Detailed description
People with diabetic foot ulcers (DFU) may live with substantial symptom burden, impaired quality of life, uncertainty, and complex care needs. Despite the serious health consequences associated with DFU, a palliative approach is not routinely integrated into DFU care. The ProActive study therefore investigates the feasibility of integrating a proactive palliative care approach into routine DFU care.
The ProActive model includes systematic procedures for identifying patients who may benefit from a palliative approach and structured serious illness conversations (SIC). The conversations provide an opportunity to discuss the patient's understanding of their health situation, concerns, priorities, and preferences for future care. Relatives may participate when appropriate.
Healthcare professionals at the participating DFU clinics receive training and support to deliver the intervention and integrate it into existing clinical practice. The implementation process is informed by the Medical Research Council framework for developing and evaluating complex interventions, with particular attention to context, stakeholder involvement, and uncertainties related to feasibility.
Study 1 investigates the feasibility of the ProActive model and its implementation from the perspective of healthcare professionals. Data are collected through observations during implementation activities and focus group interviews with healthcare professionals (N=14). Particular attention is given to the acceptability, appropriateness, and feasibility of the intervention and its implementation in routine DFU care.
Study 2 explores patients' and relatives' experiences of the ProActive model and SIC. Patients participating in the intervention, and relatives when applicable, are invited to qualitative interviews exploring their experiences of the conversation and the relevance and acceptability of introducing a proactive palliative approach in DFU care. The study includes up to 20 patients and their relatives.
Study 3 evaluates the feasibility of outcome measures and data collection procedures intended for use in a future effectiveness evaluation. Patient-, relative-, and healthcare professional-reported measures are collected to assess completion, timing, participant burden, and the suitability of the selected measures and procedures. The study includes up to 50 patients and their relatives where applicable, and 14 healthcare professionals.
Study 4 evaluates the procedures used to identify and recruit patients who may benefit from the ProActive model. All patients with DFU referred to the participating clinics during the 12-month test phase (N=400) are included in a retrospective assessment of identification and recruitment procedures and selected clinical outcomes.
Findings from the four sub-studies will be integrated to assess the overall feasibility of the ProActive model and its implementation and to identify refinements needed before a future evaluation of effectiveness.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Health care professionals | – | –Healthcare professionals involved in the care of patients with diabetic foot ulcers (DFU) at the participating clinics. Healthcare professionals will take part in the structured implementation activities, including workshops and communication training, and will subsequently deliver the ProActive intervention, including adapted serious illness conversations (SIC), as part of routine DFU care. |
| Patients and relatives- interview | – | –Patients with diabetic foot ulcers (DFU) receiving care at the participating clinics and, where applicable, their relatives. Patients will receive the ProActive intervention, including an adapted serious illness conversation (SIC) as part of routine DFU care. Patients and relatives will subsequently be invited to participate in interviews exploring their experiences of the ProActive intervention, including the SIC and the proactive palliative care approach. |
| Patients and relatives- questionaires | – | –Patients with diabetic foot ulcers (DFU) receiving care at the participating clinics and, where applicable, their relatives. Participants will complete questionnaires to assess the feasibility of selected outcome measures and data collection procedures for a future effectiveness evaluation of the ProActive intervention. Patients will complete questionnaires before the intervention and at 1 and 3 months after the intervention, while relatives will complete a questionnaire according to the study procedures. |
| Patients - retrospective clinical data | – | –All patients with diabetic foot ulcers (DFU) referred to the participating clinics during the 12-month test phase. Routinely collected clinical data will be used retrospectively to assess the feasibility of the patient identification and recruitment procedures and to describe relevant clinical outcomes during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (8 listed)
- -Not involved in DFU care or in the implementation or delivery of the ProActive model at the participating sites.
- Unable to provide informed consent.
- Do not otherwise meet the relevant inclusion 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability of the ProActive model assessed by AIM
Time frame: After the 3-month test phase
Acceptability of the ProActive model will be assessed among clinicians using the Acceptability of Intervention Measure (AIM). AIM consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater perceived acceptability.
Feasibility of the ProActive model assessed by FIM
Time frame: After the 3-month test phase
Feasibility of the ProActive model will be assessed among clinicians using the Feasibility of Intervention Measure (FIM). FIM consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater perceived feasibility.
Appropriateness of the ProActive model assessed by IAM
Time frame: After the 3-month test phase
Appropriateness of the ProActive model will be assessed among clinicians using the Intervention Appropriateness Measure (IAM). IAM consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater perceived appropriateness.
Clinician experiences of ProActive implementation assessed by focus group interviews
Time frame: After the 3-month test phase
Clinicians' experiences of implementing ProActive in routine diabetic foot ulcer care will be explored through post-intervention focus group interviews. Interviews will address implementation, local adaptation, interdisciplinary collaboration, barriers and facilitators, and integration into routine clinical practice.
Patient and relative experiences of Status Conversations assessed by interviews
Time frame: Approximately 3 weeks after the Status Conversation
Patient and relative experiences of ProActive will be explored through semi-structured interviews after participation in a Status Conversation. Interviews will address experiences of being met with a proactive palliative care approach, perceived relevance and timing of the Status Conversation, preparation, emotional impact, involvement of relatives, and perceived benefits and challenges.
Feasibility of patient-reported questionnaire completion
Time frame: Baseline, 1 month, and 3 months after the Status Conversation
Feasibility of patient-reported questionnaire completion will be assessed descriptively using response rates, completeness of questionnaire data, missing data, and timing of completion for patient-reported questionnaires.
Feasibility of identification procedures for Status Conversations
Time frame: During the 12-month test phase, with retrospective assessment after 1-year follow-up
Feasibility of identification procedures will be assessed descriptively using the proportion of eligible patients assessed for potential relevance for a Status Conversation, identified as potentially relevant, offered a Status Conversation, and accepting or declining the conversation.
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 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer (DFU) and Palliative Care, run by Ulla Riis Madsen.
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 12 inclusion and 8 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ulla Riis Madsen, PhD (+4593576367, urm@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the ProActive model assessed by AIM (time frame: After the 3-month test phase). The study lists 7 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 24 Aug 2026.