An evaluation of different devices to detect diabetic neuropathy in feet of diabetic patients

Comparison of devices for the detection of diabetic neuropathy; an evaluative diagnostic study. (short title: ‘MANDARIN’ , Medipin Assessment for Neuropathy in Diabetes, A Real-world INvestigation)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85524728

Enrollment

139

Registered

2023-08-24

Start date

2023-05-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic neuropathy Nutritional, Metabolic, Endocrine

Interventions

For this study, GP records will be screened to identify patients who have type II diabetes , and who meet the other inclusion criteria. Eligible patients will be invited to complete a postal survey. F

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged >=18 years 2. Patients with type II diabetes mellitus

Exclusion criteria

Exclusion criteria: 1. Aged <18 years 2. Any reasons for the patient being unable to follow the protocol, including lack of mental capacity to consent to taking part in the study (examples include dementia, severe learning disability). 3. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives (examples include receiving palliative care, active cancer treatment, patient immobile) 4. Amputation of a lower limb 5. Confirmed and ongoing wound/ulcer located on the foot

Design outcomes

Primary

Measure	Time frame
This study has only one study visit. At this visit, three primary outcome measures – all intended to screen for presence of diabetic neuropathy in the feet: 1. A 10g Monofilament device test will be conducted on the five plantar locations on both left and right foot. Presence of sensation will give 1 point each time; a score of 8 or lower indicates the presence of diabetic neuropathy. 2. A 10g Monofilament device test will be conducted four times on on dorsal side of hallux, proximal to toenail, on both left and right foot. Presence of sensation will give 1 point each time; a score of 3 or lower indicates the presence of diabetic neuropathy. 3. A Medipin device test will be conducted, one application on dorsal side of hallux, proximal to toenail, on both left and right foot. . Presence of sensation will give 1 point each time; a score of 1 or 0 indicates the presence of diabetic neuropathy	—

Measure

Time frame

This study has only one study visit. At this visit, three primary outcome measures – all intended to screen for presence of diabetic neuropathy in the feet: 1. A 10g Monofilament device test will be conducted on the five plantar locations on both left and right foot. Presence of sensation will give 1 point each time; a score of 8 or lower indicates the presence of diabetic neuropathy. 2. A 10g Monofilament device test will be conducted four times on on dorsal side of hallux, proximal to toenail, on both left and right foot. Presence of sensation will give 1 point each time; a score of 3 or lower indicates the presence of diabetic neuropathy. 3. A Medipin device test will be conducted, one application on dorsal side of hallux, proximal to toenail, on both left and right foot. . Presence of sensation will give 1 point each time; a score of 1 or 0 indicates the presence of diabetic neuropathy

—

Secondary

Measure	Time frame
Measured at a single time point: 1. Age, years of diabetes, smoking status, blood pressure medication and diabetes medication, presence of any foot malformations measured using patient records 2. General quality of life score (EQ-5Q-DL) 3. Michigan Neuropathy Screening Instrument (MNSI) symptom questionnaire score	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026