1 Centre for Sport and Exercise Science, Sheffield Hallam University, U. K. 2 York Trials Unit, Department of Health Sciences, University of York, U. K. 3 Health Economics and Decision Science, ScHARR, University of Sheffield, U. K. 4 School of Sport and Exercise Science, University of Lincoln, U. K. 5 Centre for Health and Social Care Research, Sheffield Hallam University, U. K. 1 Centre for Sport and Exercise Science, Sheffield Hallam University, U. K. 2 York Trials Unit, Department of Health Sciences, University of York, U. K. 3 Health Economics and Decision Science, ScHARR, University of Sheffield, U. K. 4 School of Sport and Exercise Science, University of Lincoln, U. K. 5 Centre for Health and Social Care Research, Sheffield Hallam University, U. K. EXPLORING THE FEASIBILITY OF IMPLEMENTING AN EXERCISE INTERVENTION IN PATIENTS WITH VENOUS ULCERATION UNDER A NATIONAL HEALTHCARE SYSTEM – A STUDY PROTOCOL, Markos Klonizakis 1, Garry A. Tew 2, Jonathan Michaels 3, Helen Crank 1, Geoff Middleton 4, Anil Gumber 5 Background Chronic venous insufficiency ( CVI ) affects % of the general population ( increasing to 10-21% in adults >50 years ), with 1-2% of these individuals developing venous ulceration. Treatment of venous ulcers places a huge financial burden on national healthcare services. Compression hosiery is currently the most common treatment for venous ulcers. However, ulceration recurrence rates are high and thus alternative therapies need to be pursued. Supervised exercise training involving a combination of aerobic and resistance exercises might be useful adjunct to compression hosiery in the prevention and treatment of venous ulcers, via favourable effects on lower - limb blood flow and vascular function. Hence we are proposing a feasibility study for a definitive randomised controlled trial of a combined exercise and compression hosiery intervention to improve health outcomes in patients with newly - diagnosed venous ulcers. Aims  Define the feasibility and characteristics of the potential outcome measures and also assess the time taken, burden and completeness of the various outcome measures in order to identify an appropriate subset of measures to use in a definitive trial.  Evaluate qualitatively [ e. g. direct patient experience of the intervention ] and quantitatively [ e. g. compliance ] our supervised exercise intervention and also test patient acceptability of the exercise programme.  Examine the strength of patient preferences for either the intervention or control arms [ qualitative data ]. Methods This is a randomised, controlled, assessor - blinded, two - center feasibility trial with two parallel groups. Eighty patients with new venous ulcers are randomly assigned to receive either a 12- week exercise programme combined with compression stockings or usual care ( compression only ). Exercising participants will undertake three sessions of supervised exercise each week ( combining walking, cycling and leg - strength and flexibility exercises ). Baseline measurements will include the collection of demographic data, health - related QoL information, clinical and exercise history, ulcer size and ABPI measurements, lower - limb cutaneous microvascular function measurements and a physical fitness assessment. Baseline measurements will be repeated at 3 and 12 months post - randomisation. A postal questionnaire follow - up will also be conducted at 6 months post - randomisation. Outcome measures will include time to reference ulcer healed, proportion of patients healed, percentage and absolute change in ulcer size, proportion of time patients are ulcer - free, Health - related QoL, Lower - limb cutaneous microvascular function and physical fitness. IONTOPHORESIS NO EDHF cGMP ACh Figure 1:- Microvascular Assessments ( Drugs and Mechanisms ) Smooth Muscle Cell Endothelium Acknowledgments This poster summarises independent research funded by the U. K. National Institute for Health Research ( NIHR ) under its Research for Patient Benefit Programme ( Grant Reference Number PB - PG ). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Figure 2:- Patient Study Journey for Eligible Participants Criteria for Success The feasibility study should proceed to a larger randomised controlled trial if : a ] An appropriate primary outcome variable is defined ; b ] At least 67% of randomised patients in the exercise group are compliant with the intervention. c ] Loss to follow - up at 12 months is less than 20%; d ] Patient preferences result in the conclusion that a randomised controlled trial is a feasible design.