Influence of cutaneous pain insensitivity on the incidence of new foot ulcers in patients with diabetic polyneuropathy

The value of loss of protective pain sensation in predicting a first ulceration of the foot in people with diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16238274

Enrollment

130

Registered

2023-05-30

Start date

2017-01-15

Completion date

Unknown

Last updated

2023-06-13

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

Conditions

First-ever foot ulcer in people with diabetes Nutritional, Metabolic, Endocrine

Interventions

This study is an examination of the pain sensitivity of the skin on the feet and its influence on the incidence of first-time foot ulceration in patients with diabetic polyneuropathy. Foot ulceration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diabetes Type 1 or 2 2. Neuropathy 3. No history of a first-ever foot ulcer

Exclusion criteria

Exclusion criteria: 1. No diabetes 2. No neuropathy 3. History of first-ever ulcer

Design outcomes

Primary

Measure	Time frame
1. First-ever ulcer occurrence measured using patient medical notes at a follow-up of 12, 24, 38, and 48 months 2. Death measured using patient medical notes by the end of the observation period	—

Secondary

Measure	Time frame
Time to first-ever ulcer measured using patient medical notes calculated using acceleration failure time (AFT) regression at one timepoint	—

Countries

Germany

Contacts

Public ContactAndrea Icks

andrea.icks@uni-duesseldorf.de+48 211 81 10989

Outcome results

None listed

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