Diabetic Foot
Conditions
Keywords
Diabetic Foot Ulcer, Huafu Shengji Ointment, Qi Deficiency and Blood Stasis Syndrome, Randomized Controlled Trial
Brief 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.
Interventions
DRUGHuafu 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.
DRUGethacridine 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
Beijing University of Chinese Medicine
Beijing Daxing District Hospital of Integrated Chinese and Western Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ulcer area | Measured once a week, for a total of 8 weeks. | Method of measuring ulcer area: Sterile transparent dressings are used to trace the edges of the ulcer, digital cameras are used to capture the images, and ImageJ is utilized for analysis and processing. |
| granulation tissue coverage | Measured once a week, for a total of 8 weeks. | Granulation tissue area coverage rate = (Area of the wound covered by granulation tissue \[mm\^2\]) / (Total wound area \[mm\^2\]) × 100% |
| ulcer volume | Measured once a week, for a total of 8 weeks. | Ulcer volume measurement method: After debridement is completed, the wound surface is dried with a dry cotton ball. Sterile saline is injected into the ulcer cavity using a sterilized syringe until the liquid level is flush with the skin. When the ulcer is a fistula, one end of the fistula is sealed with sterile transparent film, and then saline is injected. The volume of the injected saline is equivalent to the volume of the ulcer. |
| the time of complete wound healing | complete wound healing (assessed up to 8 weeks) | Digital cameras capture images, documenting the process of wound from the ulcerative state to the complete in situ healing of the skin tissue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| skin color | Measured once a week, for a total of 8 weeks. | 0 Normal skin color 1. Intermittently pale skin 2. Persistently pale skin 3. Skin appears purplish-cyanotic 4. Skin appears purplish-black or black |
| aspartate aminotransferase | Measured once a week, for a total of 8 weeks. | The reference range is 0-40 U/L. |
| the extent of wound exudate | Measured once a week, for a total of 8 weeks. | Covered with a 10 cm × 10 cm single-layer sterile gauze, scored based on the number of layers of gauze soaked through by exudate over 24 hours 0 1 layer 1. 2 layers 2. 3 layers 3. 4 layers 4. ≥ 5 layers |
| serum creatinine | Measured once a week, for a total of 8 weeks. | Reference range value: Males 53-106 μmol/L, Females 44-97 μmol/L |
| electrocardiogram | Measured once a week, for a total of 8 weeks. | During the study period, the P wave, P-R interval, QRS complex, and QT interval of the electrocardiogram will be assessed. |
| urea nitrogen | Measured once a week, for a total of 8 weeks. | Reference range value 3.2-7.1 mmol/L |
| alanine aminotransferase | Measured once a week, for a total of 8 weeks. | The reference range is 0-40 U/L. |
| the skin temperature around the wound | Measured once a week, for a total of 8 weeks. | 0 Normal 1. Intermittently feels cold 2. Persistently cold, but can be relieved with warming measures 3. Persistently cold, and cannot be relieved with warming measures 4. Even with stronger warming measures than usual in a 20°C environment, still feels cold. |
| the degree of pain | Measured once a week, for a total of 8 weeks. | 0 No pain 1. Pain occurs with activity or exertion 2. Intermittent pain at rest 3. Persistent pain at rest, but tolerable 4. Severe persistent pain, sleepless nights, and pain relief requires analgesics |
Outcome results
None listed