Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT02912858
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.
Study:
NCT02912858
Study Brief:
Protocol Section:
NCT02912858