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Trial registered on ANZCTR


Registration number
ACTRN12621000299808
Ethics application status
Approved
Date submitted
20/01/2021
Date registered
18/03/2021
Date last updated
30/08/2021
Date data sharing statement initially provided
18/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Addressing diabetic foot ulcer trajectories through social genomics research
Scientific title
Addressing diabetic foot ulcer trajectories through social genomics research
Secondary ID [1] 303223 0
Nil known
Universal Trial Number (UTN)
U1111-12640227
Trial acronym
MOM-DFU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 320374 0
Diabetic Foot Disease 320375 0
Condition category
Condition code
Metabolic and Endocrine 318275 318275 0 0
Diabetes
Cardiovascular 318641 318641 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 318642 318642 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
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.
Intervention code [1] 319532 0
Not applicable
Comparator / control treatment
One cohort has diabetic foot disease, and the other cohort has diabetes and no diabetic foot disease.
Control group
Active

Outcomes
Primary outcome [1] 326258 0
Percentage of diabetic foot ulcers healed - defined as 100% epithelialisation with no exudate through physical examination by treating podiatrist.
Timepoint [1] 326258 0
At every appointment attended (typically 1-2 weeks) for 2 years, or until 100% epithelialisation occurs.
Secondary outcome [1] 390789 0
Time to ulcer healing as measured by prospectively tracking ulcer progress from initial presentation to the date the ulcer healed - defined as 100% epithelialization with no exudate by the treating clinician. Percentage healing will be monitored with the use of eKare 3D imaging camera that measures wound size (length, width and depth) and plots healing percentages. This will be compared with date of initial ulcer and the date when the clinician identifies the ulcer as healed.
Timepoint [1] 390789 0
At participant follow up at routine appointments (every 1-2 weeks) during the participants involvement in the study (2 years)
Secondary outcome [2] 390790 0
Identify and map alterations in participants mental wellbeing with the tool: EQ-5D-5L
Timepoint [2] 390790 0
Questionnaires to be completed at recruitment, and then every six months for two years, or until the ulcer heals.
Secondary outcome [3] 390791 0
Identification of ulcer deterioration defined as increase in size, depth, or deterioration of tissue quality, through review of medical record, participant presentation to the service, and tracking of ulcer size through eKare wound imaging device.
Timepoint [3] 390791 0
At participants routine High Risk Foot service review (typically every 1-2 weeks), and formally reviewed every 3 months.
Secondary outcome [4] 392065 0
Identification of diabetic foot ulceration infection defined as Wound Infection foot Ischemia (WIfI) Infection grade 1-3 through review of ulceration at routine appointments, presentation to the Emergency Department or emergency presentation to the service.
Timepoint [4] 392065 0
At participants routine High Risk Foot Service review (typically every 1-2 weeks), at emergency presentation to service (for infection management), or presentation to the Emergency Department during the active phase of follow up (2 years).
Secondary outcome [5] 392066 0
Admission to hospital related to the diabetic foot ulcer as measured through medical record.
Timepoint [5] 392066 0
At routine appointments, and review of participants medical record monthly tracked throughout the participants involvement in the study (2 years).
Secondary outcome [6] 392067 0
Surgical intervention related to diabetic foot ulceration defined as debridement, drainage or amputation of the foot or leg identified through review of the medical record.
Timepoint [6] 392067 0
At routine appointments, and review of participants medical record monthly tracked throughout the participants involvement in the study (2 years).
Secondary outcome [7] 392068 0
Determine cognitive status of patients with diabetes and diabetic foot disease using the Iowa Trail Making tool and the RUDAS (Rowland Universal Assessment Scale).
Timepoint [7] 392068 0
At recruitment
Secondary outcome [8] 392471 0
Determine sleep quality and disturbance using the Pittsburgh Sleep Quality Index
Timepoint [8] 392471 0
At recruitment and every six months for two years, or until ulcer heals.
Secondary outcome [9] 392472 0
Determine alcohol, smoking and substance involvement using the WHO Assist Questionnaire
Timepoint [9] 392472 0
At participant recruitment.
Secondary outcome [10] 392764 0
Identify and map alterations in participants mental well being with the tool: Wound Quality of life
Timepoint [10] 392764 0
Questionnaires to be completed at recruitment, and then every six months for two years, or until the ulcer heals.
Secondary outcome [11] 392765 0
Identify and map alterations in participants mental well being with the tool: Beck Depression Index
Timepoint [11] 392765 0
Questionnaires to be completed at recruitment, and then every six months for two years, or until the ulcer heals.
Secondary outcome [12] 392766 0
Identify and map alterations in participants mental well being with the tool: UCLA Loneliness Scale
Timepoint [12] 392766 0
Questionnaires to be completed at recruitment, and then every six months for two years, or until the ulcer heals.
Secondary outcome [13] 392767 0
Identify and map alterations in participants mental well being with the tool: Multidimensional Scale of Perceived Social Support.
Timepoint [13] 392767 0
Questionnaires to be completed at recruitment, and then every six months for two years, or until the ulcer heals.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Malignant ulcers
- Ulcers associated with chemotherapy
- Venous Ulceration
- Thermal injuries
- Uncontrolled anticoagulation therapy (warfarin, clopidogrel, and INR > 2.0)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Clinical metrics and microbiome data will be analysed through SPSS.
DNA and RNA data will be analysed using in house genomic workflows.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18473 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 18474 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 32783 0
2170 - Liverpool
Recruitment postcode(s) [2] 32784 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 307631 0
Government body
Name [1] 307631 0
South Western Sydney Local Health District
Country [1] 307631 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Liverpool Hospital
75 Elizabeth Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 308316 0
Other
Name [1] 308316 0
South West Sydney Limb Preservation and Wound Research
Address [1] 308316 0
Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool NSW 2170
Country [1] 308316 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307674 0
South Western Sydney Local Health District Ethics Committee
Ethics committee address [1] 307674 0
Ethics committee country [1] 307674 0
Australia
Date submitted for ethics approval [1] 307674 0
09/11/2020
Approval date [1] 307674 0
25/11/2020
Ethics approval number [1] 307674 0
2020/ETH02409

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108090 0
Dr Matthew Malone
Address 108090 0
Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool 2170
NSW Australia
Country 108090 0
Australia
Phone 108090 0
+61 02 8738 9260
Fax 108090 0
+61 2 8738 8297
Email 108090 0
matthew.malone@westernsydney.edu.au
Contact person for public queries
Name 108091 0
Saskia Schwarzer
Address 108091 0
Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool 2170
NSW Australia
Country 108091 0
Australia
Phone 108091 0
+61 2 8738 9262
Fax 108091 0
+61 2 8738 8297
Email 108091 0
saskia.schwarzer@health.nsw.gov.au
Contact person for scientific queries
Name 108092 0
Matthew Malone
Address 108092 0
Ingham Institute of Applied Medical Research
1 Campbell Street
Liverpool 2170
NSW Australia
Country 108092 0
Australia
Phone 108092 0
+61 02 8738 9260
Fax 108092 0
+61 2 8738 8297
Email 108092 0
matthew.malone@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data is not necessarily reflective of the overall outcome, and is confidential and sensitive.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.