NCT06487117

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

The Efficacy and Safety Assessment of Huafu Shengji Ointment in Patients With Diabetic Foot of Qi Deficiency and Blood Stasis Syndrome: A Study Protocol for a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Daxing District Hospital of Integrated Chinese and Western Medicine · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
DRUG	Huafu Shengji Ointment	Huafu Shengji Ointment 1. The experimental group received conventional medical treatment: diabetes-related knowledge education, blood sugar control, blood pressure reduction, blood lipid regulation, antiplatelet drugs, vasodilation, nerve nutrition, and the use of antibiotics. 2. The experimental group receive local debridement: iodophor disinfection, saline cleaning, removal of necrotic tissue, and wound exposure. 3. 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.
DRUG	ethacridine lactate solution	ethacridine lactate solution 1. The control group received conventional medical treatment: diabetes-related knowledge education, blood sugar control, blood pressure reduction, blood lipid regulation, antiplatelet drugs, vasodilation, nerve nutrition, and the use of antibiotics. 2. The control group receive local debridement: iodophor disinfection, saline cleaning, removal of necrotic tissue, and wound exposure. 3. 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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-07-05
• Last updated: 2024-07-05