1. Shengji ointment combined with bromelain promotes granulation of exposed tendons in diabetic foot ulcers: A multicenter, randomized, positive-controlled clinical trial
- Author
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Xu Sun, Jinpeng Jing, Rui Dai, Chaojun Zhu, Yuzhi Sun, Junchao Sun, Dayong Li, Xin Li, Xiaoli Zhang, Xiaoliang Li, Yue Shi, Tingting Liu, Rui Gao, and Zhaohui Zhang
- Subjects
Shengji ointment ,Bromelain ,Diabetic foot ulcer ,Tendon injuries ,Traditional Chinese medicine ,Topical ,Science (General) ,Q1-390 ,Social sciences (General) ,H1-99 - Abstract
Background: Exposed, infected and necrotic tendons often occur in the middle and late stages of diabetic foot ulcers (DFUs). The exposed tendon is both a potential source and route of infection, which prolongs the treatment period and affects recovery, leading to amputation and even death. Therefore, management of the exposed tendon in patients with DFU is the key to treatment. This study aimed to evaluate the clinical efficacy of Shengji ointment combined with bromelain in the treatment of DFU with tendon exposure and to provide clinical treatment options and evidence-based medicine. Methods: This study was a multicenter, nonblinded, randomized, positive controlled clinical trial involving 180 patients with DFU with tendon exposure at four tertiary-grade A-class hospitals. The included patients were randomly assigned 1:1 to an observation group (n = 90) that received Shengji ointment combined with bromelain and a control group (n = 90) that received hydrocolloid dressing, with dressing changes once daily for 4 weeks. Patients in both groups continued with conventional treatments, such as blood glucose and blood pressure medication, lipid regulation, and antiplatelets. The primary outcome measure was wound coverage with granulation tissue. The secondary outcome measures included the wound healing rate, time to granulation, Maryland foot score, time to debridement of necrotic tendon tissue, and granulation tissue score. We performed measurements before enrollment and after the end of treatment for comparison. Results: There was no significant difference in the baseline data between the two groups before treatment (P > 0.05). After treatment, the primary outcome indicators of the two groups were compared, and the wound granulation tissue coverage rate of the treatment group was greater than that of the control group (P = 0.003). For the secondary outcome outcomes, the wound healing rate, time to granulation, Maryland foot function score, time to debridement of necrotic tendon tissue, and granulation tissue score in the treatment group were significantly better than those in the control group (P
- Published
- 2024
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