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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot

NCT06062576

Diabetic Foot Therapeutics

RECRUITING PHASE4

Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcer

NCT06197412

Diabetic Foot Ulcer Treatment

RECRUITING PHASE4

Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management

NCT06841237

Diabetic Wound Wound Infection Wound Heal

NOT_YET_RECRUITING NA

Clinical Evaluation and Generalized Application of "Qing-Hua-Bu" Three Dynamic Sequential Therapy of Diabetic Ulcer

NCT03574935

Diabetic Foot Ulcer, Skin

UNKNOWN PHASE2

Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

NCT00839865

Diabetic Foot Ulcer

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Huafu Shengji Ointment

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.

Group Type EXPERIMENTAL

Huafu Shengji Ointment

Intervention Type DRUG

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.

ethacridine lactate solution

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.

Group Type ACTIVE_COMPARATOR

ethacridine lactate solution

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No