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Clinical observation of therapeutic effect on venous leg ulcer of cold atmospheric plasma gel

Clinical observation of therapeutic effect on venous leg ulcer of cold atmospheric plasma gel

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062932
Enrollment
Unknown
Registered
2022-08-24
Start date
2022-08-25
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

venous leg ulcer

Interventions

Group A:Debridement+cold atmospheric plasma PLEL gel
Group B:Debridement+PLEL gel

Sponsors

Department of Dermatology, The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Aged from 18 to 80, male and female unlimited; 2)Patients with venous leg ulcer were diagnosed according to diagnostic criteria; 3)CEAP is classified as C6; 4)Ulcer area less than 20cm2; 5)Vital signs stable; 6)To sign the informed consents.

Exclusion criteria

Exclusion criteria: 1. Ulcers caused by ischemic disease, such as thromboangiitis obliterans, arteriovenous, inferior vena cava, diabetic foot, and arteriosclerosis obliterans; 2. Combined with other immune diseases that may lead to lower limb ulcers; 3. Radioactivity ulcer, cancerous ulcer, tuberculosis ulcer and other non lower limb venous ulcers; 4. Ulcers involve deep tissues, including bone tissues and joints; 5. Received systematic treatments in 8 weeks, treated with antibacterial agents in 4 weeks; 6. Severe allergic constitution, allergic to known drugs in the study or contraindicated; 7. Patients with severe liver or kidney dysfunction, cardiopulmonary insufficiency, serious diseases of digestive tract or blood system, a history of severe systemic disease, malignant tumor or mental illness; 8. A history of hepatitis b or c, or HIV antibody positive; 9. Smoking patients and uncontrollable diabetes; 10. The female patients who are pregnant or in the suckling periods; 11. Patients who dropped out or did not follow the established experimental plan for some reason; 12. Other conditions that the researchers considered inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
Efficacy index;

Secondary

MeasureTime frame
Dermatology Life Quality Index;

Countries

China

Contacts

Public ContactCheng chuantao
tommy.cheng@xjtu.edu.cn+86 18629596228

Outcome results

None listed

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