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

Neuropathy Clinical Trial

— TURBO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316210
• Other study ID #: FKD-TURB-001
• Status: Completed
• Phase: Phase 0
• First received: June 5, 2014
• Last updated: March 8, 2016
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Edema
• Neuropathy
• Oedema

Intervention

Device:
• electrical stimulation

Locations

Country	Name	City	State
United Kingdom	BMI Harbour hospital	Poole	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observable foot twitch in response to stimulation with Digitimer DS7A	Upon application of the electrical stimulation, parameters required to achieve an outward deflection of the foot will be measured	up to 2 hours	No
Secondary	adverse events	Any adverse events recorded during the study will be recorded	up to 2 hours	Yes
Secondary	oedema	oedema will be measured to classify the level of swelling in the participants leg	up to 2 hours	No
Secondary	patient rated tolerability questionnaire	Upon sufficient electrical stimulation to gain an outward deflection of the foot the patient will be asked to complete a tolerability questionnaire	up to 2 hours	No