NCT02211495

Brief Summary

The investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

November 4, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

August 5, 2014

Results QC Date

September 18, 2019

Last Update Submit

November 3, 2020

Conditions

Diabetes

Keywords

Diabetic FootUlcer healingMedical device to increase blood flow in foot

Outcome Measures

Primary Outcomes (1)

  • Number of Day Until 50% Healing of Leg Ulcer

    Time to 50% healing of leg ulcer, as measured by volume (3D camera)

    8 weeks

Secondary Outcomes (1)

  • Quality of Life (PAID, EQ5D, VAS, SF-12)

    6 weeks

Study Arms (2)

No device

ACTIVE COMPARATOR

Treated with best medical therapy

Other: Best Medical Therapy

Device

EXPERIMENTAL

As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.

Device: GEKO deviceOther: Best Medical Therapy

Interventions

GEKO deviceDEVICE

Placed on the lateral aspect of the knee, when activated it causes the leg to twitch

Device
Best Medical TherapyOTHER

Seen in outpatient clinic for wound care and ongoing advice

DeviceNo device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years old
  • Type 2 diabetes on best medical therapy

You may not qualify if:

  • Pregnancy
  • Pacemaker
  • Metal implants in the legs (below knee)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetic Foot Clinic, Praed Street, Paddington

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Neuropathies

Results Point of Contact

Title
Miss Kate Williams
Organization
Imperial College London
k.williams@imperial.ac.uk

Study Officials

  • Kate Williams

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 7, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 20, 2020

Results First Posted

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)