Geko Venous Leg Ulcer Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-10-10

Brief Summary

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This study is designed to look at the effect of the geko device on the circulation in lower limbs of participants with venous leg ulcers.

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Detailed Description

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Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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geko device

Group Type EXPERIMENTAL

geko

Intervention Type DEVICE

neuromuscular electrostimulator

Interventions

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geko

neuromuscular electrostimulator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. Intact healthy skin at the site of device application
3. Able to understand the Patient Information Sheet
4. Willing to give informed consent
5. Willing to follow the requirements of the protocol
6. Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 2 cm2 and less than 10 cm in maximum diameter,
7. ABPI of 0.8 or greater

Exclusion Criteria

1. History of significant haematological disorders or DVT with the preceding six months
2. Pregnant
3. Pacemakers or implantable defibrillators
4. Use of any other neuro-modulation device
5. Current use of TENS in pelvic region, back or legs
6. Use of investigational drug or device within the past 4 weeks that may interfere with this study
7. Recent surgery (such as abdominal, gynaecological, hip or knee replacement)
8. Recent trauma to the lower limbs
9. Size of leg incompatible with the geko™ device.
10. Chronic obesity (BMI \> 34)
11. Any medication deemed to be significant by the Investigator
12. Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension
13. Diabetic subjects with advanced small vessel disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No