Heliyon (Nov 2024)
Shengji ointment combined with bromelain promotes granulation of exposed tendons in diabetic foot ulcers: A multicenter, randomized, positive-controlled clinical trial
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 < 0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P = 0.444). Conclusions: Shengji ointment combined with bromelain effectively promotes the removal of exposed necrotic tendons in patients with DFU, promotes the regeneration of healthy granulation tissue, accelerates wound healing, and protects the limb and its function. It also appears to be safe as an intervention for the treatment of patients with DFU. Trial registration: The study protocol was registered in the Chinese Clinical Trial Registry (ChiCTR) under the code ChiCTR2000039327 on October 23, 2020. The public title is “Study on evidence-based evaluation and therapeutic mechanism of integrated Chinese and Western medicine for treatment of diabetic foot - An evidence-based evaluation of The combination of Rubber Shengji Paste and compound bromelain to promote the healing of the exposed wound of diabetic foot tendon”.
