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Clinical Trials/DRKS00014744
DRKS00014744
Completed
N/A

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

St. Josef- und St. Elisabeth- Hospital gGmbH0 sites20 target enrollmentMay 17, 2018
ConditionsI87.21

Overview

Phase
N/A
Intervention
Not specified
Conditions
I87.21
Sponsor
St. Josef- und St. Elisabeth- Hospital gGmbH
Enrollment
20
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 17, 2018
End Date
October 26, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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