Diabetic foot ulcer Skin and Connective Tissue Diseases
Conditions
Interventions
Population: 12 to 20 patients with healed foot ulcers. Ulcer healing is defined as complete epithelialisation of the original ulcer maintained for 4 weeks and will be confirmed by the research podiatr
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 and less than 80 years old 2. Able and willing to give written informed consent 3. Diabetes (according to WHO criteria) 4. Distal symmetrical polyneuropathy confirmed by Michigan Neuropathy Screening Instrument (MNSI) score >3 with Loss of Protective Sensation (LOPS) as defined by any loss of sensation as per MNSI assessments. 5. Healed plantar diabetic foot ulcer 6. Doppler ultrasound positive for at least one pedal pulse in each foot 7. Able to understand and willing to comply with all the study requirements 8. Be available for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Active diabetic foot ulcers 2. Non-diabetic neuropathies 3. Active alcohol or substance abuse 4. Registered blind 5. Active/acute Charcot neuroarthropathy (chronic Charcot foot is not an exclusion criterion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility assessed using: 1. The time needed to collect and analyse data (in days) measured at the end of the study 2. Screening logs of recruitment and retention strategies: the number of eligible participants, different methods of identifying/recruiting patients and willingness of clinicians to recruit participants, measured at the end of the study 3. Follow-up rates, response rates to questionnaires and adherence/compliance rates, measured at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Performance (repeated measures difference test) and reliability of the PelliTec pads to reduce pressure in patients with diabetic foot disease reported as a reduction in pressures measurements before or after using the pads across a range of activities and repeated measurements measured using research-grade insoles at the end of the study 2. Barriers and facilitators to adoption of medical devices in the management of diabetic foot ulcers by undertaking an initial feasibility/usability evaluation of participants' experience of wearing the pads, assessed using qualitative data from patient feedback at the end of the study | — |
Countries
England, United Kingdom
Outcome results
None listed