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

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.

Timeline

Start

2024-09

Primary completion

2025-12

Completion

2025-12

Publications

• 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.
• 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.
• 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.
• 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.

Drugs

Indications

No indication recorded.