A Randomized Controlled Trial of Shengji Ointment Combined with Bromelain in Promoting Healing of Tendon-Exposed Diabetic Foot Wounds: Metabolomics Profiling Analysis

Background: Diabetic foot tendon exposures are prone to infection, necrosis, and prolonged treatment cycles, not only hindering wound healing but potentially leading to amputation and life-threatening complications. Shengji ointment combined with bromelain has demonstrated preliminary efficacy in treating these wounds, but its mechanisms of action and impact on wound metabolites require further investigation.
Methods: Thirty patients with diabetic foot tendon exposure wounds received four-week treatment with Shengji ointment combined with bromelain. Clinical outcomes including granulation tissue coverage and wound healing rates were evaluated. Wound exudates collected pretreatment and posttreatment underwent metabolomics analysis to characterize treatment-induced metabolic changes.
Results: Following treatment, significant improvements were observed in granulation tissue coverage and wound healing rates compared to pretreatment baseline. Metabolomic profiling identified 4034 differential metabolites (1907 upregulated, 2127 downregulated), revealing significant alterations in key metabolic pathways including phenylpropanoid biosynthesis, tyrosine metabolism, and amino acid biosynthesis pathways.
Conclusion: Shengji ointment combined with bromelain effectively promotes healing of diabetic foot wounds with tendon exposure through significant modulation of the wound metabolic environment, particularly via regulation of critical metabolic pathways. These metabolomics findings provide mechanistic insights supporting this treatment approach.