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Addressing diabetic foot ulcer trajectories through social genomics research

Addressing diabetic foot ulcer trajectories through social genomics research

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000299808
Acronym
MOM-DFU
Enrollment
8
Registered
2021-03-18
Start date
2021-03-02
Completion date
Unknown
Last updated
2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to find out the impact of social and intrinsic factors that impact and influence the health outcomes of people with diabetic foot ulcers (DFU). We believe that determinants such as comorbidities, blood sugar control, and socioeconomic factors majorly impact host immune and bodily process pathways. We hope to identify markers that identify people who may develop chronic ulcers, infections, and predict poor health outcomes. These markers may allow us to develop targeted therapeutics, target resources, and make individualized treatment plans. The primary focus of the work is to improve patient care, quality of life and reduce the burden on DFUs.

Interventions

Participants who have been diagnosed with diabetes mellitus will be observed for three years in a longitudinal prospective study. We will be collecting data on two cohorts: Cohort 1: people with a diabetic foot ulcer, and Cohort 2: people with diabetes (and no foot ulcer). Both Cohorts will have a standard set of data collected. This data collection will be through questionnaires and validated tools and will include information on: addiction, medication adherence, sleep disturbance, social adv

Participants who have been diagnosed with diabetes mellitus will be observed for three years in a longitudinal prospective study. We will be collecting data on two cohorts: Cohort 1: people with a diabetic foot ulcer, and Cohort 2: people with diabetes (and no foot ulcer). Both Cohorts will have a standard set of data collected. This data collection will be through questionnaires and validated tools and will include information on: addiction, medication adherence, sleep disturbance, social adversity, beliefs, diet, activity. We will also collect demographic data (age, sex), medical history (type of diabetes, duration of diabetes, medical diagnoses), cognitive impairment, neurovascular foot assessment and patient reported outcomes (quality of life, wound concerns). Cohort 1: Will have ongoing data collection over the three years. This will be at set timepoints (every 3 months) or if a sentinel event of interest occurs, such as infection, admission to hospital or amputation. We will also collect ongoing information on the ulcer, deterioration and healing and treatment modalities (antibiotics, antimicrobial use, advanced wound care). There will also be a smaller sub analysis group in this cohort, who will have the same data collected, and in addition tissue and blood samples at the set time points. The initial data collection will take approximately 1 hour. Subsequent data collection will take approximately 30 minutes. Cohort 2: Will have a one off data collection. This will take approximately 1 hour to complete.

Sponsors

South Western Sydney Local Health District
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All participants: Type 1 or 2 Diabetes Mellitus Aged over 18 years Consent to participate Cohort 1 inclusion criteria: Diabetic Foot ulcer below the malleolus Cohort 2 inclusion criteria No history of diabetic foot disease

Exclusion criteria

- Malignant ulcers - Ulcers associated with chemotherapy - Venous Ulceration - Thermal injuries - Uncontrolled anticoagulation therapy (warfarin, clopidogrel, and INR > 2.0)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026