An observational study in Diabetic Ulcers, sponsored by The First Affiliated Hospital of University of South China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by The First Affiliated Hospital of University of South China · Observational
This clinical trial involves collecting peripheral blood, ulcer tissue, and fecal samples from diabetic ulcer patients for bioinformatics analysis to screen genetic markers significantly associated with ulcer risk and healing differences. Furthermore, multi-omics data will be integrated to establish a diabetic ulcer risk prediction model. Based on key single nucleotide polymorphisms and their regulatory pathways, potential new drug targets for promoting healing will be explored, providing a genetic basis for personalized treatment.
359 studies on the registry are indexed under Ulcer; 62 are open to participants now.
This study's planned enrollment of 712 is above the median of 100 across 55 observational studies indexed under Ulcer.
Browse Ulcer studies →The First Affiliated Hospital of University of South China is the lead sponsor of 13 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of diabetic ulcer patients who visit the The First Affiliated Hospital of University of South China during the trial period and meet the inclusion/exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ulcer Healing Time
Time frame: Three years
Absolute Change in Ulcer Area
Absolute change in ulcer area over three years in cm2
Time frame: Three years
Number of Amputation Events
Time frame: Three years
Ulcer Recurrence
Number of diabetic foot ulcers with recurrence at three years
Time frame: Three years
Time to Complete Wound Closure
Time to 100% wound closure utilizing Cox proportional hazards model, a statistical measure of difference of time to event (healing). The analysis will consider covariates that might influence the outcome in the trial.
Time frame: Three years or wound closure
Number of Foot Infections
Time frame: Three years
Quality of Life Assessment
The Cardiff Wound Impact Schedule questionnaire to measure quality of life. Measure of well-being items from each scale are summated, physical symptoms, everyday living and social life. The items are rated for the extent of the experience and each item is given a number value. This allows the patients to weight the items included in the scale. The well-being scale is scored on a 5-point Likert scale, with response options from 'strongly agree' to 'strongly disagree'. All three scales are then transformed onto a minimum = 0 up to a maximum = 100, where a low score indicates worse, and a high score indicates better feeling of well-being.
Time frame: Three years
Length of Stay
Time frame: Three years
Plan to share: No
No publications or documents are linked to this record.
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The First Affiliated Hospital of University of South China