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Multi center clinical study of TCM Comprehensive regimen in the treatment of refractory venous ulcer of lower extremity

Multi center clinical study of TCM Comprehensive regimen in the treatment of refractory venous ulcer of lower extremity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16009210
Enrollment
Unknown
Registered
2016-09-15
Start date
2016-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Refractory lower extremity varicose ulcer

Interventions

Traditional Chinese medicine treatment group:Qu-fu and Sheng-ji Therapy
Western medicine control group:Vaseline qauze + bFGF

Sponsors

Longhua Hospital of Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis is based on diagnostic criteria of Western Medicine; 2. Diagnosis is based on diagnostic criteria of Chinese Medicine; 3. Males and females, aged between 18 and 75 years old; 4. The area of ulcer of lower limb ulcer below knee joint is greater than or equal to 2 cm2 and less than 25 cm2; 5. Sign the informed consent forms.

Exclusion criteria

Exclusion criteria: 1. does not meet the diagnostic criteria and inclusion criteria; 2. with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious diseases, mental patients, cancer or AIDS patients; the serum creatinine and blood urea nitrogen is 1.5 times the upper limit of the normal value; the ALT is greater than the upper limit of the normal value; the clinical significance of arrhythmia; 3. pregnant or lactating women, allergic constitution or abnormal liver function; 4. patients with severe infection, the severity of the disease; 5. patients with combined nutritional disorders; 6. artery disease ulcer; cancerous ulcer or tuberculous ulcer, radiation ulcer, bedsore, leprosy, syphilis ulcer ulcer; 7. ulcer and see tendon, bone exposure; 8. above the knee or knee below the lower limb ulcer, ulcer of lower limb wound area is more than 25cm2, or less than 2 cm 2; 9. did not meet the inclusion criteria, not required medication, can not determine the effect, or incomplete information affect the efficacy or safety judgement; 10. according to the researchers to determine, with the possibility of reducing the group into the group of other medical history, such as the complexity of the work, such as frequent changes in the working environment, likely to cause loss of access to the situation; 11. subjects participating in clinical trials of other drugs.

Design outcomes

Primary

MeasureTime frame
Wound healing rate;

Secondary

MeasureTime frame
Wound healing time;Wound healing rate;would rotten tissue removing time;would rotten tissue removing rate;TCM syndrome;

Countries

China

Contacts

Public ContactHuafa QUE

Longhua Hospital of Shanghai University of Traditional Chinese Medicine

huafaque@163.com+86 18917763260

Outcome results

None listed

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