The Efficacy and Safety Assessment of Huafu Shengji Ointment in Patients With Diabetic Foot of Qi Deficiency and Blood Stasis Syndrome

Beijing Daxing District Hospital of Integrated Chinese and Western Medicine

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Diabetic Foot

Treatments: Drug: Huafu Shengji Ointment; Drug: ethacridine lactate solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06487117

YJB2024030103

Details and patient eligibility

About

Diabetic foot ulcers, as a complication of diabetes with high disability and mortality rates, have become a significant global healthcare burden and medical challenge worldwide. The clinical situation of chronic non-healing ulcers leading to repeated amputations has not yet been resolved. In preliminary clinical practice, Huafu Shengji Ointment has been shown to significantly improve the complete healing rate of ulcer wounds. This study aims to further comprehensively evaluate the therapeutic effects of Huafu Shengji Ointment and provide high-quality evidence.

Enrollment: 60 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who meet the following criteria will be included:

1. Patients who meet the diagnostic criteria for diabetic foot and have a Wagner grade of 1-5.
2. It is in line with the syndrome type of qi deficiency and blood stasis in traditional Chinese medicine.
3. Age between 35 and 80 years
4. The patient had no serious cardiac, liver, renal insufficiency or other systemic infections.
5. No hereditary or infectious diseases, no malignant tumors, and no severe malnutrition in patients.
6. Have understood the treatment modality and voluntarily signed the informed consent form.

Exclusion criteria

Patients who meet any of the following criteria will be excluded:

1. Patients who experience severe allergic reactions to the experimental medication and cannot undergo treatment.
2. Patients with poorly controlled serious conditions such as diabetic ketoacidosis, ketoacidosis, or diseases of the liver and kidneys.
3. Patients with psychiatric disorders or severe depression.
4. Women who are pregnant or breastfeeding.
5. Patients with severe organic tumors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Huafu Shengji Ointment

Experimental group

Description:

After debridement, Huafu Shengji Ointment is applied topically with a coverage thickness of 1mm, followed by sterile gauze dressing. The dressing is changed every other day. The treatment period is 4-8 weeks.

Treatment:

Drug: Huafu Shengji Ointment

ethacridine lactate solution

Active Comparator group

Description:

After debridement, the wound is cleaned and disinfected with ethacridine lactate solution, then covered and dressed with sterile gauze. The dressing is changed every other day. The treatment period is 4-8 weeks.

Treatment:

Drug: ethacridine lactate solution