Pilot study for evaluating the implementation of a evidence-based and patient-oriented care concept for the treatment of venous leg ulcers in general practitioner practices ("Ulcus Cruris Care")

Pilot study for evaluating the implementation of a evidence-based and patient-oriented care concept for the treatment of venous leg ulcers in general practitioner practices ("Ulcus Cruris Care") - Ulcus Cruris Care (Pilot)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024421

Enrollment

Registered

2021-02-19

Start date

2020-12-22

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous leg ulcers

Interventions

Group 1: Family practices receiving the interventions (e-learning, standard operating procedures, educational material for patients, software module for documentation, monitoring and treatment plannin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Practices: Participation of a medical assistant in wound care, IT requirements for the use of the “CareCockpit” software available, informed consent given Patients: Medically diagnosed UCV; Age at least 18 years; informed consent given

Exclusion criteria

Exclusion criteria: Medical practices: no involvement of medical assistants in wound care; IT requirements for using the “CareCockpit” software not given; no informed consent given Patients: presence of a relevant PAD of the affected lower extremity, confirmed by an arterial occlusive pressure of less than 50 mmHg determined by an examination of the ankle-arm pressure index (English: Ankle-brachial-index); Presence of diabetic foot syndrome; Presence of pyoderma gangrenosum; lack of ability to consent; Age under 18 years;

Design outcomes

Secondary

Measure	Time frame
Severity of chronic venous insufficiency (CVI) / presence of varicose veins (according to CEAP classification); Ulcer size (cm2); Number of relapses, duration of remission (days), health-related quality of life (EQ-5D-5L); Pain (VAS); Depression (PHQ-9); Patient satisfaction and education (PACIC-5A); Use and costs of medical and nursing services (adapted FIMA questionnaire); Number of doctor-patient contacts, number of drugs, bandages and aids prescribed in the context of wound treatment; Costs for aids prescribed as part of wound treatment; Number of microbiological swabs carried out; Number of fully completed e-learning modules; Duration of use of the e-learning modules; Number of patients who received guideline-compliant compression therapy; Adherence to the therapy plan	—

Measure

Time frame

Severity of chronic venous insufficiency (CVI) / presence of varicose veins (according to CEAP classification); Ulcer size (cm2); Number of relapses, duration of remission (days), health-related quality of life (EQ-5D-5L); Pain (VAS); Depression (PHQ-9); Patient satisfaction and education (PACIC-5A); Use and costs of medical and nursing services (adapted FIMA questionnaire); Number of doctor-patient contacts, number of drugs, bandages and aids prescribed in the context of wound treatment; Costs for aids prescribed as part of wound treatment; Number of microbiological swabs carried out; Number of fully completed e-learning modules; Duration of use of the e-learning modules; Number of patients who received guideline-compliant compression therapy; Adherence to the therapy plan

—

Primary

Measure	Time frame
wound healing rate after 12 weeks	—

Countries

Germany

Contacts

Public ContactThomas Fleischhauer

Universitätsklinikum Heidelberg Abteilung Allgemeinmedizin und Versorgungsforschung

Thomas.Fleischhauer@med.uni-heidelberg.de+49 6221 56-32864

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026