deltatrials
Terminated NA INTERVENTIONAL 2-arm NCT03958539

Prevention of Primary Foot Ulcers in High-risk Diabetes Patients (PROFOUND)

Prevention of Primary Foot Ulcers in High-risk Diabetes Patients (PrOFoUnD): a Cluster Randomised Trial of 3D Printed Insoles Versus Standard Care

Sponsor: Countess of Chester NHS Foundation Trust

Updated 6 times since 2019 Last updated: Feb 12, 2025 Started: Sep 1, 2019 Primary completion: Apr 1, 2023 Completion: Feb 12, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Funding during the pandemic

This NA trial investigates Diabetes Mellitus and Foot Ulcer, Diabetic and is currently terminated or withdrawn. Countess of Chester NHS Foundation Trust leads this study, which shows 6 recorded versions since 2019 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jun 2019 – ~Jan 2021 · 19 months · monthly snapshotNot Yet Recruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotNot Yet Recruiting~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshotUnknown~Mar 2025 – present · 16 months · monthly snapshotTerminated

Change History

6 versions recorded
  1. Mar 2025 — Present [monthly]

    Terminated NA

    Status: UnknownTerminated

  2. Sep 2024 — Mar 2025 [monthly]

    Unknown NA

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown NA

    Status: Unknown StatusUnknown

  4. Oct 2021 — Jul 2024 [monthly]

    Unknown Status NA

    Status: Not Yet RecruitingUnknown Status

  5. Jan 2021 — Oct 2021 [monthly]

    Not Yet Recruiting NA

Show 1 earlier version
  1. Jun 2019 — Jan 2021 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Countess of Chester NHS Foundation Trust
  • Staffordshire University
  • University of Liverpool
Data source: Countess of Chester NHS Foundation Trust

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations