Peripheral Neuropathy Trial, Recruiting NCT06084052 Sponsor: Royal Free Hospital NHS Foundation Trust Condition: Peripheral Neuropathy
Back to Peripheral Neuropathy

Peripheral Neuropathy Trial, Recruiting

NCT06084052
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to give informed consent to take part in research.
  • People who are 18 years of age or older at the time of giving consent.
  • People who have been diagnosed with either Type 1 or Type 2 Diabetes.
  • People who currently have no open sores or ulcers on either foot.
  • People who are willing to take part and are able to attend follow-up appointments as required.
  • People whose diabetes-related foot health has been classified as 'High Risk' according to the FRAME (2021) risk assessment system used in Scotland and England.
  • People who are able to walk more than 100 metres on their own, without a wheelchair, walking stick, or help from another person.
  • People who are able and willing to wear suitable footwear as required by the trial.
  • People who own a mobile phone and are willing to download and use the trial's app (called the WWP app).

Who may not be able to join:

  • People where either foot has been found to have fewer than two working blood vessels on a Doppler scan (confirm with trial site).
  • People with very poor vision or who are registered blind, unless they have a carer to support them.
  • People who are currently taking part in another clinical trial of a medical device or drug, or who have done so within the 30 days before enrolling in this trial.
  • People with a Body Mass Index (BMI) over 40.
  • People who already use custom-made insoles and footwear made specifically for their feet.
  • People whose foot size means they are unable to use 'medium' or 'large' insoles — for example, those with very small or extra-large feet.
  • People who have a pacemaker.
  • People who are pregnant.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Richard Leigh, BSc, Royal Free London NHS Foundation Trust

Phone: +44208302749

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Royal Free Hospital NHS Foundation Trust
Registry
ClinicalTrials.gov
Start date
2 April 2024
Est. completion
31 December 2025

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]; Changes Quality of Life Measurement; Device questionnaire; Control Group questionnaire

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov