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)

Not Applicable

• Conditions: Venous leg ulcers

• Registration Number: DRKS00024421
• Lead Sponsor: niversitätsklinikum Heidelberg Abteilung Allgemeinmedizin und Versorgungsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-19
• Study Completion: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

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

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;

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
wound healing rate after 12 weeks

Secondary Outcome Measures

Name	Time	Method
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);<br>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