Methods
gangrene, claudication, pain
OSTEOARTHRITIS OF HIP, PAD, GANGRENE, SKIN ULCERS
The study was a two-arm, parallel group, randomized controlled feasibility trial conducted in Sheffield (UK), which was developed and delivered as current standard practice.Patients were recruited from the claudication clinics by Sheffield Vascular Institute of Sheffield Teaching Hospitals NHS Foundation Trust.Eligibility criteria included: (1) diagnosed PAD with stable claudication (i.e., symptomatic presentation unchanged for 6 months); and (2) ankle–brachial index (ABI) ⩽ 0.9. Exclusion criteria included: (1) stents in the artery system of the thigh; (2) ABI > 0.89; (3) symptomatic presentation of rest pain, skin ulcers, or gangrene; and (4) impaired walking by a non-PAD condition (e.g., osteoarthritis of hip or knee joint) or cannot walk without a walking aid.All patients provided written informed consent. As this was a feasibility study, no formal sample size calculation was required. The aim was a sample of 30 patients, which is suitable for a feasibility trial to provide sufficient precision of the mean and variance.