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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot; Diabetic Foot Ulcer
• Intervention / Treatment: Other: Main questionnaire; Other: Optional 12-week follow up questionnaire

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Aleksandra Olszewska; Phone Number: 07584028128; Email: aleksandra.olszewska@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • King's College London
    • Contact: Aleksandra Olszewska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Adult (>18 years old)
2. Diagnosed with diabetes
3. Currently having or have had at least one diabetic foot ulcer incident in the past
4. Resident in England
5. Able to consent

Exclusion Criteria:

1. Underaged
2. Not diagnosed with diabetes
3. Never had a DFU incident
4. Unable/refusing to consent
5. A non-English resident

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	- Logistic regression models obtained to understand the association between diabetic comorbidities/prescribed medications and the characteristics of a diabetic foot ulcer (severity and recurrence).	9 months
Established changes to DFU status and quality of life over the 12 week follow up period.	Quantified the change in quality of life over 12-week period and testing the association by performing a t-test between the DFU incident outcome and quality of life (based on the answers to the EQ-5D-5L).	9 months

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Biotechnology and Biological Sciences Research Council; Biotherapy Services Limited
• Investigators: Principal Investigator: Ben Forbes, Professor, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: diabetes; environmental factors; diabetic foot ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 312284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only processed data will be shared. No individual responses/raw data is planned to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No