Effect of FlowOx™ treatment on healing of lower limb ischaemic ulcers
Research type
Research Study
Full title
Pilot study to test the clinical efficacy of FlowOx™ home treatment compared to standard care in patients with critical limb ischemia and lower limb ulcers
IRAS ID
214180
Contact name
Christopher Nester
Contact email
Sponsor organisation
University of Salford
Duration of Study in the UK
0 years, 10 months, 29 days
Research summary
Lower limb peripheral artery disease (PAD) is a manifestation of systemic atherosclerotic disease. PAD is associated with an increase in morbidity, reduction in mobility and quality of life and in its severe form, such as critical limb ischemia (CLI), can lead to tissue loss (ulceration), gangrene and lower limb amputation. This health burden has led to an increased focus on non invasive therapeutic interventions aimed at improving the clinical signs and symptoms of CLI and wound healing, especially in a cohort that is deemed unable to benefit from surgery. Even the use of the best pharmacologic agents result in a modest improvement of symptoms, such as intermittent claudication and rest pain. Although drug therapy, control of risk factors and revascularisation procedures can prove beneficial in CLI, a number of patients deteriorate leading to loss of tissue viability. Some patients experience failed revascularisation procedures or are contraindicated for such procedures, which make the clinical management of such patients a therapeutic challenge.
The development of home-use devices that apply intermittent pneumatic foot and/or leg compression has been shown to improve arterial flow to the lower limb, however there are safety risks associated with these devices as well as a dearth of robust clinical evidence to support their clinical efficacy. The use of intermittent negative pressure (INP) therapy has also been explored in this context. Case study data on the effects of INP therapy have shown promising results, such as improved haemodynamic outcomes and ischaemic ulcer healing in patients with PAD. Although the results of the cases studies have been promising (references cited later in the application), a more systematic approach to data collection is required in order to answer specific questions about the efficacy of the treatment before proceeding with a randomised control trial (RCT). This pilot study will test the effects of INP therapy (trade name FlowOx™) on lower limb chronic ischaemic wounds compared to standard treatment. The outcomes of the study will inform the design of an appropriately powered RCT. The focus will be on collecting objective outcome measures, such as: wound healing rates; effective (and pragmatic) INP doses; quality of life outcomes and health economics data. Subjective opinions of the treatment will be sought via patient and clinician focus groups.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0089
Date of REC Opinion
22 Feb 2017
REC opinion
Favourable Opinion