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NCT06025422
In-shoe Pressures Associated With Footwear Fit Guidelines
trial in Diabetic Foot Ulcer in 26 participants. Completed in 30 June 2025.
30 June 2025
Quick facts
| Lead sponsor | University Hospitals, Leicester |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 26 |
| Start date | 15 December 2022 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across United Kingdom |
Conditions studied
- Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
- Diabetic Neuropathies — all drugs for Diabetic Neuropathies →
Sponsor
University Hospitals, Leicester
Who can join
Adults 18 to 80, any sex, with Diabetic Foot Ulcer or Diabetic Neuropathies. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
One in five foot ulcers are caused by the footwear worn by people with diabetes, yet there is a lack of consensus around footwear fit. Recommended toe gaps (the gap between the longest toe and the inside of the shoe) vary depending on the footwear guidance referred to but no research to date has assessed the recommendations' effectiveness in minimising in-shoe pressures. The investigators will carry out a pilot study in 60 people with diabetes and loss of foot sensation (neuropathy). In this study, the investigators will measure in-shoe pressures whilst participants walk at the same pace to the beat of a metronome. An insole placed inside participants' shoes will measure in-shoe pressures. Participants will wear the same (standardised) type of footwear. The study is designed to detect a difference in pressure within this made-to-measure footwear whose fit conforms to Standard 1 guidance compared with footwear whose fit conforms to Standard 2 guidance. Differences between Standards 1 and 2 with Standard 3 will be considered secondary analyses. Standards are simplified to three non-overlapping recommended toe gap ranges of 0.5-1.0cm; 1.5-2.0cm and 1.0-1.5cm. The investigators will also analyse the heat images taken with a thermographic camera before and after walking in standardised footwear whose fit confirms to these standards (this is known as the plantar thermal stress response to walking). Footwear fit will be determined by measuring the dimensions of participants' feet and that of participants' footwear and comparing the two. The investigators will also measure footwear fit and associated in-shoe pressure/plantar thermal stress response in participants' habitual footwear during walking at paced and self-selected speeds.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06025422
- Europe PMC full search
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Related trials
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Currently open trials in the same condition.
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- NCT07291817 — Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study · NA · recruiting
- NCT07209358 — EDX110 Randomized Control Trial for Treatment of DFUs · NA · recruiting
- NCT06938685 — Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers · NA · recruiting
Other University Hospitals, Leicester trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06025422 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospitals, Leicester
- Last refreshed: 5 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06025422.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing