Specialty: Cardiovascular disease, Primary sub-specialty: Atherothrombosis
Conditions
Interventions
Participants will be randomised with a 2:1 weighting between the two groups: FlowOx™ and standard clinical care, respectively. The random allocation sequence will be generated by the study statisticia
Sponsors
University of Salford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 07/08/2018: 1. Recent successful lower limb revascularization procedure 2. Male and female patients, aged 18 years and over with PAD, including patients with diabetes 3. Capacity to understand the nature of the study and provide informed consent 4. Diagnosis of critical lower limb ischaemia based on clinical signs and symptoms and confirmed by diagnostic imaging such as Duplex/computer tomographic angiography/magnetic resonance angiography/digital subtraction angiography 5. Critical lower limb ischaemia classified as based on recommendations of STAMP (43) 6. Critical limb ischaemia, Absent foot pulses AND monophasic or absent Doppler signals PLUS 2 of: Ischaemic Rest Pain, Ankle systolic 7. Grade 0 - 2 wound of the lower extremity (according to the WIfI, grading system (44)) present and non-healing for at least 6 weeks (45). 8. Treated foot/shoe size = 46 (European size), which corresponds to approximate foot length = 29.5 cm. This is required for the correct fitting of the FlowOx™ device. 9. Maximum circumference of calf should be 41cm for correct fitting of the FlowOx™ device Participants who are not suitable for revascularisation but who meet all other inclusion/exclusion criteria will be invited to participate in a case study to evaluate the use of the device. Previous participant inclusion criteria: 1. Male and female patients, aged 18 years and over with PAD including patients with diabetes 2. Capacity to understand the nature of the study and provide informed consent 3. Diagnosis of critical lower limb ischaemia based on clinical signs and symptoms and confirmed by diagnostic imaging such as Duplex/computer tomographic angiography/magnetic resonance angiography/digital subtraction angiography 4. Critical lower limb ischaemia classified as based on recommendations of STAMP 5. Critical limb ischaemia: absent foot pulses AND monophasic or absent Doppler signals PLUS 2 of: Ischaemic rest pain, ankle systolic <50mmHg, deteriorating wound 6. Grade 0 - 2 wound of the lower extremity (according to the WIfI, grading system ) present and non-healing for at least 6 weeks. 7. Treated foot/shoe size = 46 (European size), which corresponds to approximate foot length = 29.5 cm. This is required for the correct fitting of the FlowOx™ device 8. Maximum circumference of calf should be 36cm for correct fitting of the FlowOx™ device 9. Patients not eligible for (or have declined) revascularization or other operative/interventional procedures OR have had operative/interventional procedures for the limb ischaemia which have failed
Exclusion criteria
Exclusion criteria: 1. Pressure ulcers 2. Venous ulcers 3. Patients with the following: vasospastic and collagen vascular disease; vasculitis; acute limb ischaemia; atheroembolic disease, and arterial trauma. 4. Patients with active eczema, psoriasis or any inflammatory skin conditions 5. Patients with a history of recent above or below knee DVT 6. Patients with a with a history of multiple DVT in the past 7. Critical limb ischaemia that is limb threatening and requires immediate assessment and surgery by a vascular surgeon (the priority is to save the limb in this case). 8. Recent or anticipated (in the next 6 months) major surgery or lower extremity revascularisation 9. Current cardiac rehabilitation (these programmes involve exercise regimes which will alter ischemic limb signs and symptoms) 10. Currently participating in a study evaluating other treatments for lower limb ischaemia 11. Cellulitis 12. Unable, unwilling or does not have the capacity to give informed consent 13. Unable to don or doff the FlowOx system at home independently or with the help of a family member (aid). 14. Those with cancer, or those who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer size is measured using 3D camera images at baseline and 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical improvement, defined as improvement in Rutherford and WIfI grading systems, is assessed by CRF at baseline, 1, 2 and 3 months 2. Bilateral Ankle Brachial Pressure Index (ABPI) is calculated by dividing the systolic blood pressure at the ankle (posterior tibial artery or dorsalis pedis artery) by the systolic blood pressure in the arm (brachial artery) at baseline, 1, 2 and 3 months 3. Bilateral Toe Brachial Pressure Index (TBPI) is measured by dividing the systolic blood pressure at the toe by the systolic blood pressure in the arm (brachial artery) at baseline, 1, 2 and 3 months 4. Rest pain is measured using centimeter Visual Analogue Scale (VAS) at baseline, 1, 2 and 3 months 5. Lower limb amputation incidence is measured by reviewing clinical records and CRF at baseline, 1, 2 and 3 months 6. Quality of life is measured using the VascuQol questionnaire at baseline, 1, 2 and 3 months 7. Generic health-related quality of life is measured using the EQ-5D-5L questionnaire at baseline, 1, 2 and 3 months 8. Quality of sleep is measured using the Pittsburgh Sleep Quality Index (PSQ) at baseline, 1, 2 and 3 months 9. Adherence to treatment program is assessed using FlowOx™ USB data and patient reports at baseline, 1, 2 and 3 months 10. Device usability data is measured using the QUEST questionnaire at baseline, 1, 2 and 3 months 11. Comfort is measured using the FlowOx™ comfort and usability questionnaire at baseline, 1, 2 and 3 months 12. Cost effectiveness (including capability outcome measures) are measured by ICECAP at baseline, 1, 2 and 3 months | — |
Countries
United Kingdom
Contacts
Public ContactFarina Hashmi
Outcome results
None listed