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Withdrawn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
Sponsored by
About this trial
This is an interventional other trial for Venous Leg Ulcer
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)
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adverse events assessments
Description
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.
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
No
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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