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A prospective, multicenter, randomized, parallel controlled and non-inferior clinical trial on the safety and effectiveness of disposable gel patch shaper in clinical use.

A prospective, multicenter, randomized, parallel controlled and non-inferior clinical trial on the safety and effectiveness of disposable gel patch shaper in clinical use.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090765
Enrollment
Unknown
Registered
2024-10-12
Start date
2024-10-14
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Chronic ulcer

Interventions

Control Group:Debridement and platelet-rich plasma gel therapy
Test group:Debridement and platelet-rich plasma gel patch therapy

Sponsors

Sir Run Run Shaw Hospital, College of Medicine Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) 18 -75 years old; 2) Patients with chronic wounds who need debridement and repair; 3) The wound duration is more than 4 weeks; 4) Voluntary participation in this study and signing of informed consent;

Exclusion criteria

Exclusion criteria: 1) Patients with severe thrombocytopenia and septicemia; 2) Patients who are allergic to rubber components; 3) Patients who have been injected with glucocorticoids within one month or received systemic corticosteroid treatment within two weeks; 4) Patients with malignant tumor; 5) Hemoglobin < 100 g/L and platelet count < 100× 109/L; 6) Mental illness, cognitive impairment, critically ill patients, minors and pregnant women; 7) Those who have participated in or are participating in clinical trials of drugs within 3 months, or participated in or are participating in clinical trials of other medical devices within 30 days; 8) Other circumstances that the researcher considers inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Platelet concentration;

Secondary

MeasureTime frame
Gel tensile strength;Growth factor concentration;Bacterial status of wound surface 3 days after operation;Postoperative wound condition;

Countries

China

Contacts

Public ContactQiang Wang

Sir Run Run Shaw Hospital, College of Medicine Zhejiang University

33720669@163.com+86 150 6889 1971

Outcome results

None listed

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