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Trial record 2 of 10 for:    fkd

Midds Ankle Fracture

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Firstkind Ltd
Sponsor:
Information provided by (Responsible Party):
Firstkind Ltd
ClinicalTrials.gov Identifier:
NCT02841007
First received: July 15, 2016
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
The geko™ device is indicated for the prevention and treatment of oedema. The aim of this study is to show that recruiting, and performing study assessments in ankle fracture patients requiring surgery to fix their ankle attending the James Cook Hospital is feasible, and to obtain data to support the powering of a larger study to demonstrate the effectiveness of the geko™ device at reducing length of stay for this population of patients. This study will also allow us to assess the acceptability, tolerability and compliance of treatment with the geko device.

Condition Intervention Phase
Ankle Fracture Requiring Internal Fixation
Device: geko neuromuscular electrostimulation device
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: gekoTM Neuromuscular Electrostimulation (NMES) Device, Pilot Feasibility Study Looking at Time to Surgery Study in Patients Requiring Ankle Fixation Following Fracture, Comparison to Matched Retrospective Controls

Resource links provided by NLM:


Further study details as provided by Firstkind Ltd:

Primary Outcome Measures:
  • Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Time to readiness for surgery [ Time Frame: 0-~7days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast [ Time Frame: 0-~7days ] [ Designated as safety issue: No ]
  • Adverse events, including the need for secondary surgery or additional treatment, serious adverse events [ Time Frame: study duration up to ~14days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2016
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: geko device arm
Patients consenting to take part will receive the geko device prior to surgery to internally fixate their fractured ankle, to reduce and prevent oedema
Device: geko neuromuscular electrostimulation device

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18-60 years old
  2. Clinically and radiologically diagnosed acute ankle fracture that, in the opinion of the treating surgeon, requires operative fixation
  3. Able to understand the Patient Information Sheet (PIS) 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. Morbid Obesity (BMI Index >40kg/m2).
  3. Patients who on presentation to hospital are known to be pregnant.
  4. Clinically significant co-morbidities that need to be treated prior to surgical intervention and could therefore impact upon time to theatre
  5. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
  6. Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
  7. Diabetic
  8. Already taking part in a clinical study, or has so within the last 8 weeks
  9. None responder to geko™ device
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02841007

Contacts
Contact: Matthew Womack, PhD 7456427910 matthew.womack@firstkindmedical.com

Locations
United Kingdom
James Cook Hospital Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Paul Baker    01642845579      
Sponsors and Collaborators
Firstkind Ltd
  More Information

Responsible Party: Firstkind Ltd
ClinicalTrials.gov Identifier: NCT02841007     History of Changes
Other Study ID Numbers: FKD-LOS-001 
Study First Received: July 15, 2016
Last Updated: July 20, 2016
Health Authority: United Kingdom: Research Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries

ClinicalTrials.gov processed this record on December 05, 2016