An interventional study of geko plus R-2 in Venous Leg Ulcer, sponsored by Firstkind Ltd. Withdrawn. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-02-07.
Sponsored by Firstkind Ltd · Not applicable, Interventional, and Other
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.
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.
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
Browse Varicose Ulcer studies →Firstkind Ltd is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
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.
Time frame: 3 months
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.
Time frame: 3 months
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Firstkind Ltd