The Efficacy and Safety Assessment of Huafu Shengji Ointment in Patients With Diabetic Foot of Qi Deficiency and Blood Stasis Syndrome
NCT Number: NCT06487117
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Diabetic Foot
Interventions: DRUG: Huafu Shengji Ointment|DRUG: ethacridine lactate solution
Sponsor: Beijing Daxing District Hospital of Integrated Chinese and Western Medicine
Collaborators: Beijing University of Chinese Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12

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.

Primary Outcome Measures: ulcer area, 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., Measured once a week, for a total of 8 weeks.|granulation tissue coverage, Granulation tissue area coverage rate = (Area of the wound covered by granulation tissue \[mm\^2\]) / (Total wound area \[mm\^2\]) × 100%, Measured once a week, for a total of 8 weeks.|ulcer volume, 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., Measured once a week, for a total of 8 weeks.|the time of complete wound healing, Digital cameras capture images, documenting the process of wound from the ulcerative state to the complete in situ healing of the skin tissue., complete wound healing (assessed up to 8 weeks)
Secondary Outcome Measures: the skin temperature around the wound, 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., Measured once a week, for a total of 8 weeks.|the degree of pain, 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, Measured once a week, for a total of 8 weeks.|skin color, 0 Normal skin color

1. Intermittently pale skin
2. Persistently pale skin
3. Skin appears purplish-cyanotic
4. Skin appears purplish-black or black, Measured once a week, for a total of 8 weeks.|the extent of wound exudate, 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, Measured once a week, for a total of 8 weeks.|alanine aminotransferase, The reference range is 0-40 U/L., Measured once a week, for a total of 8 weeks.|aspartate aminotransferase, The reference range is 0-40 U/L., Measured once a week, for a total of 8 weeks.|urea nitrogen, Reference range value 3.2-7.1 mmol/L, Measured once a week, for a total of 8 weeks.|serum creatinine, Reference range value: Males 53-106 μmol/L, Females 44-97 μmol/L, Measured once a week, for a total of 8 weeks.|electrocardiogram, During the study period, the P wave, P-R interval, QRS complex, and QT interval of the electrocardiogram will be assessed., Measured once a week, for a total of 8 weeks.