I87.21
Conditions
Interventions
Group 1: The "FlowAid" device is used in the pilot study. By means of probes, which are glued to the skin at four points of the lower leg, the underlying calf muscles are to contract by electrical sti
Sponsors
St. Josef- und St. Elisabeth- Hospital gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: o Men and women o Age > 18 years o BMI up to 40 kg/m2 o Written consent o Patient in the vein centre o Primarily venous ulcer (recurrence or initial manifestation), diagnosis verified by DPPG and duplex sonography o Duration of the wound for at least 3 months o Stable wound progression with no healing tendency despite standard therapy in accordance with guidelines for at least 4 weeks (incl. phase-appropriate wound therapy and sufficient compression therapy) o Possibility and willingness to participate o Reduced mobility in the ankle/arthrogenic congestion syndrome
Exclusion criteria
Exclusion criteria: o acute TVT/ OVT (< 6 months) o lack of intellectual capacity to agree and answer questions o lack of motor skills or home help for the home use of FlowAid according to the protocol o Contraindications for the use of Flowaid o significant other cause of venous leg ulcer o short-term necessity of in-patient therapy o Pregnancy and lactation o ABI < 0.5 or absolute systolic ankle artery pressure < 60mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the study is to observe the influence of FlowAid on the course of wound healing in venous leg ulcers. The most important criterion here is the wound size (max. length, max. width). This is documented in four rounds (at the beginning, one week later, five weeks after start and nine weeks after start). The treatment period is set at five weeks, a final assessment will be made four weeks later. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the primary criterion of wound size, the following factors are also assessed: o Exudation o Granulation o Pain o Quality of life o Infection o Course of healing o Handling Flowaid These are collected directly and with the help of questionnaires. | — |
Countries
Germany
Contacts
Public ContactMaren Hoffmann
Venenzentrum St. Maria-Hilf Krankenhaus
Outcome results
None listed