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A clinical trial of Fuzheng Heying recipe in treatment of severe diabetic foot gangrene

Phase 1
Conditions
diabetic foot
Registration Number
ITMCTR2200006700
Lead Sponsor
shanghai TCM-Integrated Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

? Those who meet the above diagnosis and have unilateral disease; ? Age 40-80 years old, Han nationality, male or female; ? Serum total protein is not less than 40 g/L, and albumin is not less than 21 g/L; ? No intravenous infusion or oral administration of drugs affecting protein synthesis, no use of enteral and parenteral nutrition within the previous month; ? Voluntary participation in this study and signed informed consent.

Exclusion Criteria

?Diabetes with ketoacidosis and malignant hypertension; ?Heart failure, complicated with liver and kidney hematopoietic system diseases; ?Malnutrition caused by other reasons, such as tumor, kidney disease (except diabetic nephropathy), liver cirrhosis, burns; ? Ankle brachial index (ABI) < 0.4, indicating severe ischemic lesions of the lower extremities; ? Patients with type I diabetes; ? Pregnant and lactating women; ? Patients with mental and intellectual abnormalities.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Effective rate of wound healing;
Secondary Outcome Measures
NameTimeMethod
TCM syndrome score;
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