Cluster-randomized controlled intervention study to evaluate the implementation of an evidence-based and patient-centered care concept for the treatment of venous leg ulcers in primary care ("Ulcus Cruris Care")

Cluster-randomized controlled intervention study to evaluate the implementation of an evidence-based and patient-centered care concept for the treatment of venous leg ulcers in primary care ("Ulcus Cruris Care") - UCC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00026126

Enrollment

Registered

2021-08-30

Start date

2022-01-24

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Venous leg ulcer

Interventions

Group 1: Intervention group 25 General practices (1 General practitioner and 1 medical assistant (MA) each) and 63 patients. Here the interventions are introduced: Webinar and e-learning for physicia

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Practices: Involvement of an MA in wound care; IT requirements for use of "CareCockpit" software available. Patients: Presence of a florid VLU for = 6 months; age = 18 years; capacity to consent.

Exclusion criteria

Exclusion criteria: Practices: no involvement of an MA in wound care; IT requirements for use of "CareCockpit" software not available; specialized practices with more than 20 VLU patients per year. Patients: Leg ulceration of non-venous origin; existence of ulceration for > 6 months; presence of a relevant PAOD of affected lower extremity (ABPI < 0.5 or ankle artery pressure < 60 mmHg); decompensated heart failure (NYHA = III); immobility; age < 18 years; no ability to give informed consent

Design outcomes

Primary

Measure	Time frame
Time to complete wound healing in days ("time-to-heal")	—

Secondary

Measure	Time frame
Number of completely healed ulcers; severity of chronic venous insufficiency (CVI) (according to Venous clinical severity score VCSS); size of ulcer (cm2); number of recurrences; duration of remission (days); health-related quality of life (EQ-5D-5L); depressiveness (PHQ-9); patient satisfaction and education (PACIC-5A) Health economic analysis: Number of physician-patient contacts; number of specialist-patient contacts; number and duration of inpatient stays; period of prescriptions for treatment care; prescribed remedies and aids; type and treatment duration of wound dressings, wound irrigation solutions, and antiseptics, antibiotics, analgesics, and dressings prescribed as part of wound treatment; frequency of wound swabs; total days of sick leave; travel distances for wound treatment. Process evaluation: number of e-learning modules completed in full; duration of use of e-learning modules; number of patients who received guideline-compliant compression therapy; knowledge assessment by multiple-choice quiz; study-specific questionnaire to evaluate the intervention; sociodemographic questionnaire to elicit contextual factors; guideline-based interviews of 10 General practitioners and 10 MAs of the intervention arm as well as 5 regional representatives from associations of health insurance, primary care physicians and nursing, and patient represantatives.	—

Measure

Time frame

Number of completely healed ulcers; severity of chronic venous insufficiency (CVI) (according to Venous clinical severity score VCSS); size of ulcer (cm2); number of recurrences; duration of remission (days); health-related quality of life (EQ-5D-5L); depressiveness (PHQ-9); patient satisfaction and education (PACIC-5A) Health economic analysis: Number of physician-patient contacts; number of specialist-patient contacts; number and duration of inpatient stays; period of prescriptions for treatment care; prescribed remedies and aids; type and treatment duration of wound dressings, wound irrigation solutions, and antiseptics, antibiotics, analgesics, and dressings prescribed as part of wound treatment; frequency of wound swabs; total days of sick leave; travel distances for wound treatment. Process evaluation: number of e-learning modules completed in full; duration of use of e-learning modules; number of patients who received guideline-compliant compression therapy; knowledge assessment by multiple-choice quiz; study-specific questionnaire to evaluate the intervention; sociodemographic questionnaire to elicit contextual factors; guideline-based interviews of 10 General practitioners and 10 MAs of the intervention arm as well as 5 regional representatives from associations of health insurance, primary care physicians and nursing, and patient represantatives.

—

Countries

Germany

Contacts

Public ContactThomas Fleischhauer

Universitätsklinikum Heidelberg Abteilung Allgemeinmedizin und Versorgungsforschung

thomas.fleischhauer@med.uni-heidelberg.de06221 56-32864

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 9, 2026