Pilot study on the use of neuromuscular stimulation (FlowAid) in patients with therapy-resistant venous leg ulcer

Not Applicable

• Conditions: I87.21

• Registration Number: DRKS00014744
• Lead Sponsor: St. Josef- und St. Elisabeth- Hospital gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-17
• Study Completion: 2021-10-26
• Results First Posted: 2023-05-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
In addition to the primary criterion of wound size, the following factors are also assessed:<br>o Exudation<br>o Granulation<br>o Pain<br>o Quality of life<br>o Infection<br>o Course of healing<br>o Handling Flowaid<br>These are collected directly and with the help of questionnaires.