Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema (TURBO)

Firstkind

Status and phase: Completed; Early Phase 1

Conditions: Oedema; Neuropathy

Treatments: Device: electrical stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02316210

FKD-TURB-001

Details and patient eligibility

About

This study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 years and over
2. Be a non-responder to the geko MK1&2 device
3. Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
4. Able and willing to follow the protocol requirements.

Exclusion criteria

1. Has a pacemaker
2. Pregnancy.
3. Is contraindicated for the MK1&2 device and/or the Digitimer DS7A
4. Recently diagnosed or suspected DVT

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Digitimer stimulation

Experimental group

Treatment:

Device: electrical stimulation