Geko Venous Leg Ulcer Study

Firstkind

Status: Completed

Conditions: Venous Leg Ulcer

Treatments: Device: geko

Study type: Interventional

Funder types: Industry

Identifiers

NCT02482038

FSK-VLU-001

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

geko device

Experimental group

Treatment:

Device: geko