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

NCT06487117 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Beijing University of Chinese Medicine

    collaborator OTHER

  • Beijing Daxing District Hospital of Integrated Chinese and Western Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06487117 on ClinicalTrials.gov