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Recruiting

NCT Number: NCT06979037

Genetic Markers of Diabetic Ulcers and Personalized Treatment Targets Research

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China

Location status: Recruiting

Location contact

Jiecan Zhou, Prof.

CONTACT

[email protected]

+86-734-8279018

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) Subjects who voluntarily participate in this clinical study and sign informed consent;
  • 2) Patients with type 2 diabetes and diabetic ulcers;
  • 3) Disease duration ≥ 10 years or age ≥ 55 years at enrollment;
  • 4) Inpatient or outpatient who can be monitored by the same investigating team throughout the duration of the study.

Exclusion criteria

  • 1) Severe vascular occlusion or impairment;
  • 2) Patients with congenital heart disease, aortic dissection, or other severe cardiovascular diseases;
  • 3) Patients with ulcers caused by factors other than diabetes;
  • 4) Patients with severe liver and kidney dysfunction or serious neurological impairment.

Treatment and study plan

Primary outcomes

  1. Ulcer Healing Time

    Time frame: Three years

Secondary outcomes

  1. Absolute Change in Ulcer Area

    Time frame: Three years

    Absolute change in ulcer area over three years in cm2

  2. Number of Amputation Events

    Time frame: Three years

  3. Ulcer Recurrence

    Time frame: Three years

    Number of diabetic foot ulcers with recurrence at three years

  4. Time to Complete Wound Closure

    Time frame: Three years or 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.

  5. Number of Foot Infections

    Time frame: Three years

  6. Quality of Life Assessment

    Time frame: Three years

    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.

  7. Length of Stay

    Time frame: Three years

Study contacts

Contact information is provided by the study sponsor or research team.

Jiecan Zhou, Prof.

CONTACT

[email protected]

+86-734-8279018

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of University of South China

Other

Registry information

Official study title

Clinical Investigation of Genetic Markers in Diabetic Ulcers and Their Role in Personalized Treatment Targeting

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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