Geko Venous Leg Ulcer Study

Not Applicable

Completed

• Conditions: Venous Leg Ulcer
• Interventions: Device: geko

• Registration Number: NCT02482038
• Lead Sponsor: Firstkind Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-25
• Study Start: 2016-09
• Primary Completion: 2018-06-05
• Study Completion: 2019-10-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
geko device	geko	-

Primary Outcome Measures

Name	Time	Method
Ultra sound measurements of haemodynamics	10mins

Secondary Outcome Measures

Name	Time	Method
Adverse event rate	2 hrs
patient rated tolerability	2 hrs	A questionnaire has been designed to record the opinion of the patient with regard to the device, in particular how comfortable the device was to wear. The patient will be asked to rate how comfortable the devices are to wear on a scale of 1-5, 1 being very comfortable and 5 being extremely uncomfortable

Trial Locations

Locations (1)

Ealing Hospital; 🇬🇧 Ealing, Middlesex, United Kingdom