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A prospective, multicenter, randomized, open, parallel controlled clinical trial of the safety and efficacy of platelet-rich plasma preparation kits for chronic wound repair

A prospective, multicenter, randomized, open, parallel controlled clinical trial of the safety and efficacy of platelet-rich plasma preparation kits for chronic wound repair

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100009
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-16
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Chronic wound

Interventions

Treatment group:Platelet-rich plasma preparation PRP prepared by kit combined with conventional treatment
Control group:Conventional treatment

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age >= 18 years and 30 g/L; 7) Hemoglobin (Hgb) >= 100 g/L and platelet count (PLT) >= 100 × 10^9/L; 8) The subject and/or their guardian can understand the purpose of the trial, demonstrate adequate compliance with the trial protocol, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) The target wound is expected to require skin grafting or flap repair; 2) dry gangrene caused by vascular disease; 3) Patients with bleeding disorders (such as hemophilia, vitamin K deficiency, etc.), disorders with platelet dysfunction (such as giant platelet syndrome, thrombocytopathia, storage pool disease, thrombocytopathia syndrome, etc.), or other blood-related diseases that researchers have judged unsuitable for platelet-rich plasma collection; 4) Patients with severe heart, liver, lung, renal failure, severe neurological disease, severe cardiovascular disease, malignant tumor, systemic infection or uncontrolled local infection (including target wound), sepsis; 5) History of systemic glucocorticoid therapy within 14 days before or during the screening period; 6) History of target wound glucocorticoid injection within 28 days before or during the screening period; 7) Pregnant or lactating women; 8) Have participated in or are participating in other interventional clinical trials within 28 days prior to screening; 9)The investigator believes that they should not be involved in other situations in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Bates-Jensen wound score 21 days after initial treatment;

Secondary

MeasureTime frame
Wound healing efficiency;Relative rate of wound healing;Visual Analogue Pain Score (VAS score);Product performance evaluation;

Countries

China

Contacts

Public ContactYuan Ting

Shanghai Sixth People's Hospital

yuanting3000@163.com+86 139 1838 5701

Outcome results

None listed

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