E11.74 L98.4 T89.03
Conditions
Interventions
Group 1: The first study examination (t0) takes place during the consultation when the indication is made or as part of the preoperative consultation 1-2 weeks before the planned operation (applicatio
Sponsors
BG Klinikum Duisburg gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: •Chronic, therapy-resistant (uncontrollable by conventional wound treatment and surgical measures) defect wound (> 6 weeks) on the lower extremity •Secure arterial blood supply (at least one patent artery to the foot) •Locally limited infection (no systemic sepsis) •Capacity to consent and written consent to participate •Willingness to undergo and follow up on TCTD therapy
Exclusion criteria
Exclusion criteria: •Critical ischemia without the possibility of revascularization •Uncontrolled sepsis or generalized infection •Malignant tumors or terminal underlying disease •Severe psychiatric illness or active addiction •Pregnancy or breastfeeding •Previous TCTD on the same segment •Insufficient knowledge of German
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete wound healing (epithelialization without fistula formation) six months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time to complete wound healing (in days) • Freedom from amputation (no major amputation) • Complications (infections, malunion, wire loosening) • Comorbidities • Mobility (e.g., ability to walk, need for assistive devices) • Pain (VAS scale 0–10) • Change in quality of life (SF12) due to the fixator • Patient satisfaction with the fixator | — |
Countries
Germany
Contacts
Public ContactAlex-Reza Nuripour
BG Klinikum Duisburg gGmbH
Outcome results
None listed