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Umbilical Cord Blood-Derived Platelet-Rich Plasma (UCB-PRP) Local Injection with Gel Coverage for Diabetic Foot: A Prospective Single-Arm Study

Umbilical Cord Blood-Derived Platelet-Rich Plasma (UCB-PRP) Local Injection with Gel Coverage for Diabetic Foot: A Prospective Single-Arm Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108274
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Diabetic foot (DF)

Interventions

Experimental group:UCB-PRP was performed

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70 years old (male or female); 2. Clinically diagnosed with type 1 or type 2 diabetes; 3. Patients with diabetic foot Wagner grade 2-4; 4. Patients with foot ulcers > for 4 weeks and no healing tendency after one week of standard wound treatment; 5.7% 30mmHg; 7. Voluntarily sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Patients with renal insufficiency, hypercortisolism, thyroid dysfunction or other endocrine disorders; 2. Wound dissemination and infection: such as massive exudation, redness, swelling, heat and pain, etc., which have not been effectively controlled; 3. Active bleeding or hematoma in the wound; 4. Patients with severe cardiovascular disease, including uncontrollable hypertension (BP>=160/95mmHg), unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure >NYHA class II., severe arrhythmias, and pericardial effusion, etc.; 5. Patients with systemic bacterial and viral infections (syphilis, hepatitis, CMV, HIV, parvovirus B19, herpes virus) and sepsis; 6. Patients with psychological or mental disorders, blood coagulation disorders, and patients with a history of allergies; 7. Other situations that the investigator considers unsuitable for enrollment;

Design outcomes

Primary

MeasureTime frame
Wound area change rate;

Secondary

MeasureTime frame
Amputation rate;Visual Analog Scale (VAS) for pain;Bates-Jensen Wound Assessment Tool;Adverse events evaluation;Complete healing rate;Ankle-brachial index (ABI);Transcutaneous oxygen pressure (TcPO?);Toe oxygen saturation;

Countries

China

Contacts

Public ContactSu Yongtao

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

yongtaosu@126.com+86 533 7698246

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026