NCT05464524

Environmental Factors on DFUs Incidence - a Mixed-mode Survey

The Role of Various Environmental Factors on the Incidence, Severity and Recurrence of Diabetic Foot Ulcers (DFUs) in Adult Patients With Diabetes in England

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 179 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: —

Summary

Diabetic foot ulcers (DFUs) pose a significant threat to the health and wellbeing of diabetic patients. Affecting around 1 in 10 people (NHS North West Coast Strategic Clinical Networks, 2017) regardless of a diabetes type they often result in a drastically worsened quality of life and can lead to severe consequences including leg amputations. This survey will help to understand what role various environmental factors have on the incidence, severity and recurrence of DFUs. Results from this study will help healthcare professionals as well as patients to better understand various factors involved in DFU prevalence. Moreover, this survey could help to appreciate whether a more holistic approach should be followed when assessing DFU risk and deciding on therapy. This study will be run across five sites in England between October 2023 and May 2024 and will involve a small pilot study (informal interview) and an anonymous, ten-minute questionnaire. Any adult with an ongoing or past DFU will be eligible. Participants will be asked about their job type, quality of life, diabetic therapy, comorbidities, and environmental factors questions. There will be an option for a follow-up questionnaire after 12 weeks to understand the healing process and changes to the quality of life following a DFU incident. Additionally, patients may consent to provide access to excerpts from their anonymized medical history details (prescribed medications) to better understand their diabetic and DFU history. This study will be run as part of an industrial, London Interdisciplinary Biosciences Consortium (LIDo) PhD project investigating the autologous platelet-rich plasma gel for diabetic foot ulcers (RAPID™ biodynamic haematogel) with King's College London as funded by the Biotechnology and Biological Sciences Research Council (BBSCR) and Biotherapy Services Ltd.

Conditions

• Diabetic Foot
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	Main questionnaire	10-15 minute questionnaire asking about environmental factors (i.e daily lifestyle questions), quality of life, comorbidities among others.
OTHER	Optional 12-week follow up questionnaire	A 5-minute questionnaire asking about changes to the quality of life and DFU status since the initial questionnaire.

Timeline

• Start date: 2023-10-19
• Primary completion: 2025-02-15
• Completion: 2025-05-30
• First posted: 2022-07-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: United Kingdom