A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device

NCT ID: NCT02884323

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-07-02

Brief Summary

This is a single centre open label study measuring lower limb physiology in patients with venous leg ulcers at the University Hospital of South Manchester.

Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes in microcirculation will be measured at baseline after the gekoTM device is activated. Ambulatory venous pressure and venous transit times will be performed whilst the participant is standing, sitting and supine

Conditions

Venous Leg Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

geko device arm

Group Type: EXPERIMENTAL

geko™ device

Intervention Type: DEVICE

The geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg.

Interventions

geko™ device

The geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg.

Intervention Type: DEVICE

Eligibility Criteria

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 and able to give informed consent

5. Willing and able 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 1 cm2 and less than 10 cm in maximum diameter,

7. ABPI of ≥0.8

8. Patient treated with 4 layer compression bandaging

Exclusion Criteria

1. Wound infection either acute or chronic

2. History of significant haematological disorders or DVT with the preceding six months

3. Pregnant

4. Pacemakers or implantable defibrillators

5. Use of any other neuro-modulation device

6. Current use of TENS in pelvic region, back or legs

7. Use of investigational drug or device within the past 4 weeks that may interfere with this study

8. Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator.

9. Recent trauma to the lower limbs

10. Size of leg incompatible with the geko™ device.

11. Obesity (BMI > 34)

12. Any medication deemed to be significant by the Investigator

13. Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension, or less than 2cm.

14. Diabetes

15. Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Firstkind Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles McCollum

Role: PRINCIPAL_INVESTIGATOR

UHSM

Locations

The University of Manchester Academic Surgery Unit 2nd Floor, ERC University Hospital of South Manchester M23 9LT

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

FSK-VLU-002

Identifier Type: -

Identifier Source: org_study_id