Environmental Factors on DFUs Incidence - a Mixed-mode Survey

NCT05464524 | Completed

• 1 other identifier: 312284
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetic foot ulcer; diabetes; environmental factors

Outcome Measures

Primary Outcomes (1)

• Established the role of tested environmental factors and lifestyle choices on the incidence, recurrence, and severity of diabetic foot ulcers in adults living with diabetes in England.

  Descriptive statistics used to characterise the study population. Logistic regression modelling of tested environmental factors to establish models quantifying the association between independent and dependent variables (DFU incidence, severity, recurrence). Identified main environmental factors that produce the highest probability of having a severe diabetic foot ulcer case (based on the answers to the EQ-5D-5L - a severe DFU incident would is predicted to influence mobility, self-care, pain levels, performance of usual activities and anxiety/depression.)

  9 months

Secondary Outcomes (2)

• Quantified the associations between the other disease co-occurring with diabetes and the medications or therapies prescribed for them that may have an impact on diabetic foot ulcer incidence and severity.

  9 months

• Established changes to DFU status and quality of life over the 12 week follow up period.

  9 months

Interventions

Main questionnaire OTHER

10-15 minute questionnaire asking about environmental factors (i.e daily lifestyle questions), quality of life, comorbidities among others.

Optional 12-week follow up questionnaire OTHER

A 5-minute questionnaire asking about changes to the quality of life and DFU status since the initial questionnaire.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult English residents with a past or present diabetic foot ulcer.

You may qualify if:

• Adult (\>18 years old)
• Diagnosed with diabetes
• Currently having or have had at least one diabetic foot ulcer incident in the past
• Resident in England
• Able to consent

You may not qualify if:

• Underaged
• Not diagnosed with diabetes
• Never had a DFU incident
• Unable/refusing to consent
• A non-English resident

Sponsors & Collaborators

• King's College London: lead
• Biotechnology and Biological Sciences Research Council: collaborator
• Biotherapy Services Limited: collaborator

Study Sites (1)

King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ben Forbes, Professor

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 19, 2022
• Study Start: October 19, 2023
• Primary Completion: February 15, 2025
• Study Completion: May 30, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)