Clinical trial NCT05464524: Environmental Factors on DFUs Incidence - a Mixed-mode Survey
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Foot
Diabetic Foot Ulcer
Keywords: diabetic foot ulcer
diabetes
environmental factors
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Biotechnology and Biological Sciences Research Council
name: Biotherapy Services Limited
First posted: 2022-07-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult English residents with a past or present diabetic foot ulcer.

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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 9 months
Secondary outcomes:
measure: 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.
timeFrame: 9 months
measure: Established changes to DFU status and quality of life over the 12 week follow up period.
timeFrame: 9 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Ben Forbes, Professor
role: PRINCIPAL_INVESTIGATOR
References: