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

NCT07781111 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 484

Last updated 2026-08-24

No results posted yet for this study

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

  • Diabetic Foot Ulcer (DFU)
  • Palliative Care
  • Advance Care Planning

Sponsors & Collaborators

  • Kolding Sygehus

    collaborator OTHER

  • REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • Steno Diabetes Center Sjaelland

    collaborator OTHER_GOV

  • Independent Research Fund Denmark

    collaborator INDUSTRY

  • OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark

    collaborator UNKNOWN

  • Ulla Riis Madsen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-12-31
Completion
2029-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781111 on ClinicalTrials.gov