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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: geko plus R-2

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 2 cm2 and less than 10 cm in maximum diameter,
7. ABPI of 0.8-1.2 inclusive

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 gekoTM plus R-2 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: geko plus R-2; neuromuscular electrostimulation	Device: geko plus R-2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Firstkind Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: FKD-IPC-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No