Genetic Markers of Diabetic Ulcers and Personalized Treatment Targets Research

NCT06979037 | Recruiting

• 1 other identifier: NHFY20240506
• Study Type: observational
• Target: 712
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Ulcers

Keywords

Diabetic Ulcers

Outcome Measures

Primary Outcomes (1)

• Ulcer Healing Time

  Three years

Secondary Outcomes (7)

• Absolute Change in Ulcer Area

  Three years

• Number of Amputation Events

  Three years

• Ulcer Recurrence

  Three years

• Time to Complete Wound Closure

  Three years or wound closure

• Number of Foot Infections

  Three years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of University of South China: lead

Study Sites (1)

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood, ulcer tissue, and fecal samples from diabetic ulcer patients will be collected and detected.

Central Study Contacts

Jiecan Zhou, Prof.

CONTACT

+86-734-8279018; zhoujiecan@fsyy.usc.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 18, 2025
• Study Start: May 16, 2024
• Primary Completion (Estimated): May 16, 2027
• Study Completion (Estimated): May 16, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)