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| Name | Class |
|---|---|
| Beijing University of Chinese Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Huafu Shengji Ointment | Experimental | 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. |
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| ethacridine lactate solution | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huafu Shengji Ointment | Drug | Huafu Shengji Ointment
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| the skin temperature around the wound | 0 Normal
| Measured once a week, for a total of 8 weeks. |
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Inclusion Criteria:
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Patients who meet the following criteria will be included:
Exclusion Criteria:
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Patients who meet any of the following criteria will be excluded:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37884128 | Background | Monaghan MG, Borah R, Thomsen C, Browne S. Thou shall not heal: Overcoming the non-healing behaviour of diabetic foot ulcers by engineering the inflammatory microenvironment. Adv Drug Deliv Rev. 2023 Dec;203:115120. doi: 10.1016/j.addr.2023.115120. Epub 2023 Oct 25. | |
| 28495183 | Background | Ibrahim A. IDF Clinical Practice Recommendation on the Diabetic Foot: A guide for healthcare professionals. Diabetes Res Clin Pract. 2017 May;127:285-287. doi: 10.1016/j.diabres.2017.04.013. Epub 2017 Apr 9. No abstract available. |
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| ethacridine lactate solution | Drug | ethacridine lactate solution
|
|
| the degree of pain | 0 No pain
| Measured once a week, for a total of 8 weeks. |
| skin color | 0 Normal skin color
| 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
| 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. |
| 25601358 | Background | Jupiter DC, Thorud JC, Buckley CJ, Shibuya N. The impact of foot ulceration and amputation on mortality in diabetic patients. I: From ulceration to death, a systematic review. Int Wound J. 2016 Oct;13(5):892-903. doi: 10.1111/iwj.12404. Epub 2015 Jan 20. |
| 34477854 | Background | Huang YY, Lin CW, Cheng NC, Cazzell SM, Chen HH, Huang KF, Tung KY, Huang HL, Lin PY, Perng CK, Shi B, Liu C, Ma Y, Cao Y, Li Y, Xue Y, Yan L, Li Q, Ning G, Chang SC. Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2122607. doi: 10.1001/jamanetworkopen.2021.22607. |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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