An observational study in Diabetic Foot Ulcer (DFU), Palliative Care and Advance Care Planning, sponsored by Ulla Riis Madsen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Ulla Riis Madsen · Observational
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.
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 484 is above the median of 100 across 191 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →This is the only study on the registry with Ulla Riis Madsen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
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
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:
Study 4:
Inclusion Criteria:
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the 12-month test phase, with retrospective assessment after 1-year follow-up
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.
Of 65 non-industry observational studies under Diabetic Foot, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 94. This study's planned 27 months is close to that.
Counting every sponsor, half of 90 studies reached it within 28 months; a quarter within 15 and three quarters within 59.
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.
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