The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care | NCT07781111 | Trialant

Not yet recruitingObservationalUpdated Aug 24, 2026

The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care

The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care. A Feasibility Study.

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07781111
Lead Sponsor: Ulla Riis MadsenOTHER
Overall Status: Not yet recruiting
Study Type: Observational
Enrollment: 484Estimated
Last Update Posted: Aug 24, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Dec 31, 2028Estimated
Completion Date: Feb 28, 2029Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care. A Feasibility Study.
Brief 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 (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.

Conditions

The medical conditions and diseases this study investigates.

Diabetic Foot Ulcer (DFU)
Palliative Care
Advance Care Planning

Interventions

The treatments and procedures being evaluated in this study.

No interventions

There are no interventions for this study.

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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.

Design

How the study is designed and how its participant groups are organized.

Observational Model: Other
Time Perspective: Other

Contacts

The people to reach with questions about this study or how to join it.

Ulla Riis Madsen, PhDContact

urm@regionsjaelland.dk+4593576367

Locations

Where the study is run and whether each site is currently recruiting.

No locations

There are no locations for this study.

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Ulla Riis MadsenOTHER
Collaborators

Similar Studies

Other registered studies that closely resemble this one.

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.