A proof-of-concept project to provide evidence that PelliTec blister prevention pads can be used safely by people with healed diabetic foot ulcers in multidisciplinary diabetic foot clinics

Not Applicable

• Conditions: Diabetic foot ulcer; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN15738632
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-24
• Last Update Posted: 11 October 2021
• Study Completion: 2023-10-17

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Feasibility assessed using:<br> 1. The time needed to collect and analyse data (in days) measured at the end of the study<br> 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<br> 3. Follow-up rates, response rates to questionnaires and adherence/compliance rates, measured at the end of the study<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br>