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A randomized controlled multicenter clinical study on the promotion of healing of venous ulcers in the lower extremities by pressure therapy

A randomized controlled multicenter clinical study on the promotion of healing of venous ulcers in the lower extremities by pressure therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123654
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Lower extremity venous ulcer

Interventions

Treatment group:Basic treatment + Class II compression stockings combined with local compression therapy
control group:Basic treatment + treatment with Class 3 compression stockings

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for chronic venous ulcers; 2. Age over 18 years; 3. Venous ulcer persists for 6 weeks or longer; 4. Ulcer area between 5 cm^2 and 50 cm^2; 5. Number of ulcers greater than or equal to 1 and less than or equal to 3; 6. Lower limb venous ultrasound diagnosis of chronic lower limb venous insufficiency (venous reflux defined as superficial vein reflux time greater than 0.5 seconds, deep vein reflux time greater than 1 second with record of deep vein reflux); 7. ABI between 0.8 and 1.3; 8. Voluntarily willing to participate in the clinical trial and sign the informed consent form. Those who meet all of the above criteria will be included.

Exclusion criteria

Exclusion criteria: 1. Individuals allergic to pressure therapy products; 2. Pregnant or breastfeeding women; 3. Those with severe heart, liver, kidney complications, or combined with other serious primary diseases, or psychiatric patients; 4. Participants currently enrolled in other clinical trials; 5. Other conditions deemed unsuitable for enrollment by the investigator. Anyone meeting any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Ulcer healing rate;Rate of Change in Governance Methods;

Secondary

MeasureTime frame
Ulcer healing time;Venous clinical severity score;Quality of Life Score for Chronic Venous Disease;Recurrent ulcer rate;Evaluation of venous blood flow dynamics;

Countries

China

Contacts

Public ContactYang You

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

petergemma@163.com+86 193 0215 6759

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026