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Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients

Primary Purpose

Venous Leg Ulcer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

geko plus R-2

About this trial

This is an interventional other trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
Intact healthy skin at the site of device application
Able to understand the Patient Information Sheet
Willing and able to give informed consent
Willing and able to follow the requirements of the protocol
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,
ABPI of 0.8-1.2 inclusive

Exclusion Criteria:

Wound infection either acute or chronic
History of significant haematological disorders or DVT with the preceding six months
Pregnant
Pacemakers or implantable defibrillators
Use of any other neuro-modulation device
Current use of TENS in pelvic region, back or legs
Use of investigational drug or device within the past 4 weeks that may interfere with this study
Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator.
Recent trauma to the lower limbs
Size of leg incompatible with the gekoTM plus R-2 device
Obesity (BMI > 34)
Any medication deemed to be significant by the Investigator
Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension, or less than 2cm.
Diabetes
Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

geko plus R-2

Arm Description

neuromuscular electrostimulation

Outcomes

Primary Outcome Measures

The lower limb blood flow between gekoTM plus R-2 and IPC devices in VLU patients will be assessed.

Duplex ultrasound of the femoral vein and artery will be performed with bilateral recording of blood flow velocity. After 10 minutes activation of either geko™ or IPC and after the 10 minutes the devices will swapped over and measurements performed. All measurements to be carried out in triplicate.

Secondary Outcome Measures

Adverse events assessments

Patients will be monitored for adverse events throughout the duration of the study. Adverse events may be spontaneously reported by the subject, observed by the study personnel. Serious Adverse Events will be reported to the Sponsor, the National Research Ethics Service (NRES) recognised Research Ethics Committee.

Full Information

NCT ID

NCT02912858

First Posted

September 16, 2016

Last Updated

February 6, 2018

Sponsor

Firstkind Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02912858

Brief Title

Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients

Official Title

Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients: Comparison of Effects on Lower Limb Circulation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Withdrawn

Why Stopped

study withdrawn

Study Start Date

September 2017 (Anticipated)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Firstkind Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Chronic venous leg ulcers (VLU) are painful, debilitating wounds that place a significant burden on the patient, their family, and healthcare resources. Treating VLU can present a significant challenge to clinicians, who currently have a limited range of treatments at their disposal. The mainstay of treatment is compression bandaging, ambulation and elevation at rest. In addition to the aforementioned, intermittent pneumatic compression has also been utilised1. When applied to the leg or foot intermittent pneumatic compression (IPC) devices intermittently inflate and deflate to increase venous return. These devices can be uncomfortable to wear, and compliance can be inhibited because of size, weight and external power source that limit the patient's mobility. In patients who cannot walk, or in those who are unable to tolerate compression bandaging, ulcers may deteriorate and never heal. Accordingly, there is a need for novel, alternative devices or strategies that can be used to complement or replace compression bandage therapy.

Detailed Description

This is a single-centre randomised intra-patient comparison of gekoTM plus R-2 R-2 and IPC. Blood flow will be measured after each device has been activated for 10 minutes with a 10 minute rest between devices to allow blood flow to return to baseline. The order the devices will be fitted is determined randomly. Activation of the device for 10 minutes before measurement is deemed appropriate as previous studies have demonstrated significant increases in blood flow following as little as five minutes use of the devices. In this short study the standard of care (typically compression bandaging), will be suspended temporarily to allow the fitting of the gekoTM plus R-2 and IPC devices in order to measure blood flow. This is not seen as a risk to the patient as the device is only in operation for 30 minutes plus 10 minutes rest within the care pathway.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

geko plus R-2

Arm Type

Experimental

Arm Description

neuromuscular electrostimulation

Intervention Type

Device

Intervention Name(s)

geko plus R-2

Intervention Description

The gekoTM plus R-2 devices (acting on the common peroneal nerve) and IPC devices will be activated for 10mins prior to measuring blood flow. The sequence of application of IPC and gekoTM plus R-2 devices will be randomly selected with 10 minutes recovery between active therapies.

Primary Outcome Measure Information:

Title

The lower limb blood flow between gekoTM plus R-2 and IPC devices in VLU patients will be assessed.

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Adverse events assessments

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Intact healthy skin at the site of device application Able to understand the Patient Information Sheet Willing and able to give informed consent Willing and able to follow the requirements of the protocol 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, ABPI of 0.8-1.2 inclusive Exclusion Criteria: Wound infection either acute or chronic History of significant haematological disorders or DVT with the preceding six months Pregnant Pacemakers or implantable defibrillators Use of any other neuro-modulation device Current use of TENS in pelvic region, back or legs Use of investigational drug or device within the past 4 weeks that may interfere with this study Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator. Recent trauma to the lower limbs Size of leg incompatible with the gekoTM plus R-2 device Obesity (BMI > 34) Any medication deemed to be significant by the Investigator Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension, or less than 2cm. Diabetes Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients

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