Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

Guiyang No.1 People's Hospital

Status and phase: Unknown; Phase 2

Conditions: Diabetic Foot Ulcer

Treatments: Drug: herb ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT00839865

NCI-197-4128D

ISRCTN20081114

SFL-2008-11

R01-020225-1

Details and patient eligibility

About

The purpose of this study is to determine if dressing change with a kind of herb Yuyang ointment is clinically more efficacious and safer than Conventional treatment in the treatment of diabetic foot ulcers.

Full description

1. Developing a Document Retrieval strategy for clinical trials of Chinese medicine treatment of diabetic foot ulcer according to the research program(finished)
2. Selecting and Evaluating the above trials,developing a methodological quality evaluation criteria(finished)
3. extract information, verification, meta-analysis, sensitivity analysis and sub-group analysis(finished)
4. comprehensive evaluating the pros and cons evidences of traditional Chinese medicine, acupuncture and Chinese and Western combined medicine with the treatment of diabetic foot of (finished)
5. we find dress change with a certain kind of herb ointment is very effective and safe to diabetic foot ulcers.The following step is randomized controlled multicenter clinical trial to verify it's efficacy and safety

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• In-patient or out-patient patients diagnosed with diabetic foot ulcers
• Gangrene or ulceration occurred more than 3 weeks
• Over 18 years of age
• Gender-open
• The type of diabetes (type 1 or type 2) open
• Patients receive a written informed consent to participate in the trial

Exclusion criteria

• Serious complications of heart, liver, lung, kidney damage
• Malignant tumors
• Allergy for Chinese medicine used
• Pregnant women and breast-feeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

herb ointment dressing change group

Experimental group

Description:

This group of patients in the ointment dressing every 2 days until Wound Healing or 6 months

Treatment:

Drug: herb ointment

Conventional dressing change group

No Intervention group

Description:

This group of patients in the Conventional dressing every 2 days until Wound Healing or 6 months