Diabetic FootNCT05464524
Environmental Factors on DFUs Incidence - a Mixed-mode Survey
An observational study of Diabetic Foot and Diabetic Foot Ulcer, run by King's College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer
- What is being tested?
- Main questionnaire and Optional 12-week follow up questionnaire
- How many people
- 179 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2023to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Adult English residents with a past or present diabetic foot ulcer.
Who may be able to join
- 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
Who cannot join
- Underaged
- Not diagnosed with diabetes
- Never had a DFU incident
- Unable/refusing to consent
- A non-English resident
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer
- Being tested
- Main questionnaire, Optional 12-week follow up questionnaire
- Keywords
- diabetic foot ulcer, diabetes, environmental factors
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Main questionnaireOther
10-15 minute questionnaire asking about environmental factors (i.e daily lifestyle questions), quality of life, comorbidities among others.
Optional 12-week follow up questionnaireOther
A 5-minute questionnaire asking about changes to the quality of life and DFU status since the initial questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
- Logistic regression models obtained to understand the association between diabetic comorbidities/prescribed medications and the characteristics of a diabetic foot ulcer (severity and recurrence).
Measured: 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).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start19 Oct 2023
- Primary completion15 Feb 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Biotherapy Services Limited
- Responsible party
- Sponsor
- Investigators
- Ben Forbes, Professor, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464524
- Sponsor's protocol ID
- 312284
- Status last verified
- Feb 2025
- First submitted
- 4 Jul 2022
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only processed data will be shared. No individual responses/raw data is planned to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Various Environmental Factors on the Incidence, Severity and Recurrence of Diabetic Foot Ulcers (DFUs) in Adult Patients With Diabetes in England
- ClinicalTrials.gov ID
- NCT05464524
- Acronym / sponsor ID
- 312284
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer
- Keywords
- diabetic foot ulcer, diabetes, environmental factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Biotherapy Services Limited
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult English residents with a past or present diabetic foot ulcer.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Underaged
- Not diagnosed with diabetes
- Never had a DFU incident
- Unable/refusing to consent
- A non-English resident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Main questionnaire10-15 minute questionnaire asking about environmental factors (i.e daily lifestyle questions), quality of life, comorbidities among others. | Other | – |
| Optional 12-week follow up questionnaireA 5-minute questionnaire asking about changes to the quality of life and DFU status since the initial questionnaire. | Other | – |
Primary outcome
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.
Time frame: 9 months
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.)
2 secondary outcomes
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.
Time frame: 9 months
Established changes to DFU status and quality of life over the 12 week follow up period.
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No. Only processed data will be shared. No individual responses/raw data is planned to be shared with other researchers.
Related trials for Diabetic Foot
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Forbes, Professor principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Diabetic Foot Ulcer, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.