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Digital, guideline-based care for hard-to-heal and/or chronic wounds - Evaluation of a multimodal healthcare approach

Digital, guideline-based care for hard-to-heal and/or chronic wounds - Evaluation of a multimodal healthcare approach - DigiLeit

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036726
Enrollment
548
Registered
2025-10-28
Start date
2026-03-22
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

chronic wounds resulting from diabetes mellitus, chronic venous insufficiency, or peripheral arterial occlusive disease

Interventions

Group 1: Intervention group A: standard care Group 2: Intervention group B: Patients are treated within the framework of the new care concept in a specialized wound healing center (WhZ). The new model

Sponsors

Hautklinik und PoliklinikUniversitätsmedizin Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Chronic wounds on the foot and/or lower leg - Insured with a public health insurance

Exclusion criteria

Exclusion criteria: - Clinical diagnosis excludes the following underlying conditions: diabetes mellitus, peripheral arterial disease, chronic venous insufficiency - Ongoing chemotherapy - Use of immunosuppressive medication - Requirement for dialysis - Individuals who refuse a physical examination - Insufficient knowledge of the German language

Design outcomes

Primary

MeasureTime frame
Proportion of patients with complete wound epithelialization 20 weeks after the start of the intervention, as assessed by a blinded nurse.

Secondary

MeasureTime frame
Secondary endpoints are: - Time to wound closure - Wound area - Signs of inflammation - Health-related quality of life - Pain assessed using the numeric rating scale - Mobility - Disease-related risk factors - Self-management competence - Treatment satisfaction - Recurrence rate - Adverse events - Quality indicators to be developed within the project for measuring guideline compliance - Costs of care

Countries

Germany

Contacts

Public ContactBrigitte Nink-Grebe

Deutsche Gesellschaft für Wundheilung und Wundbehandlung e.V. Studienzentrum

dgfw@dgfw.de+49 641 3019835

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026