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

Early Phase 1

Completed

• Conditions: Oedema; Neuropathy
• Interventions: Device: electrical stimulation

• Registration Number: NCT02316210
• Lead Sponsor: Firstkind Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-12
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digitimer stimulation	electrical stimulation	-

Primary Outcome Measures

Name	Time	Method
Observable foot twitch in response to stimulation with Digitimer DS7A	up to 2 hours	Upon application of the electrical stimulation, parameters required to achieve an outward deflection of the foot will be measured

Secondary Outcome Measures

Name	Time	Method
adverse events	up to 2 hours	Any adverse events recorded during the study will be recorded
oedema	up to 2 hours	oedema will be measured to classify the level of swelling in the participants leg
patient rated tolerability questionnaire	up to 2 hours	Upon sufficient electrical stimulation to gain an outward deflection of the foot the patient will be asked to complete a tolerability questionnaire

Trial Locations

Locations (1)

BMI Harbour hospital; 🇬🇧 Poole, Dorset, United Kingdom