Chronic diabetic foot wounds after debridement avital tissue components Chronic diabetic foot wounds after amputation below the articulatio talocruralis E10.74 E10.75 E11.74 E11.75
Conditions
Interventions
Group 1: Negative Pressure Wound Therapy
Group 2: Standard wound therapy according to current evidence-based guideline
(basic and advanced methods of wound treatment)
Sponsors
Private Universität Witten / Herdecke gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Presence of diabetes mellitus; Presence of a foot wound (chronic wounds; amputational wounds) Wagner stage 2-4; Existence of the foot wound for at least 4 weeks; Signed informed consent form; Patient's eligibility of NPWT in the opinion of the treating physician
Exclusion criteria
Exclusion criteria: Age <18 years; Pregnancy; Non-Compliance; Allergies regarding the release of substances from components of each treatment arm; Severe anemia, which was not caused by an infection; Simultaneous participation of patients in another interventional study / previous participation in the same study; Use of NPWT systems to the study-related foot lesion within a period of 6 weeks prior to study inclusio; Presence of necrotic tissue with eschar, which can not be removed; Untreated osteitis or osteomyelitis; Not examined / unexplored fistula; Malignancy of the wound; Exposed: nerves, blood vessels, anastomotic site; ambulant NPWT of patients receiving anticoagulants (especially heparinization or marcumar therapy) or with otherwise highly impaired clotting function, which have a risk of circulatory relevant bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of achieved and confirmed wound closures within a maximum treatment time of 16 weeks plus the time until complete wound closure (in days) The wound closure is defined as 100% epithelialization; no need for drainage, no need for supportive therapy or a means of assistance and absence of suture material. The closure must remain at least for a period of 14 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time until optimal preparation of the wound bed for further therapy (granulation of at least 95%); Time to reach a complete wound closure within the observation period of 6 months; Recurrences; Amputations (appearance and dimension); Wound size over time; Proportion of wound tissue qualities over time; all SAEs within 6 months; wound specific and device specific AEs within the active study treatment time of 16 weeks or until end of therapy; Pain (NRS) within the active study treatment time of 16 weeks or until end of therapy; Quality of Life (EQ-5D) within 6 months; direct costs (medical and non-medical); indirect costs | — |
Countries
Germany
Contacts
Public ContactDörthe Seidel
Institut für Forschung in der Operativen Medizin Private Universität Witten/Herdecke gGmbH
Outcome results
None listed