Dataset Information

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

ABSTRACT:

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.

INSTRUMENT(S): Liquid Chromatography MS - negative - reverse phase, Liquid Chromatography MS - positive - reverse phase

PROVIDER: MTBLS12713 | MetaboLights | 2025-07-14

REPOSITORIES: MetaboLights

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			Action	DRS
	a_MTBLS12713_LC-MS_negative_reverse-phase_metabolite_profiling.txt	Txt
	a_MTBLS12713_LC-MS_positive_reverse-phase_metabolite_profiling.txt	Txt
	i_Investigation.txt	Txt
	m_MTBLS12713_LC-MS_negative_reverse-phase_metabolite_profiling_v2_maf.tsv	Tabular
	m_MTBLS12713_LC-MS_positive_reverse-phase_metabolite_profiling_v2_maf.tsv	Tabular

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Project description:OBJECTIVE: To assess the safety and efficacy as well as determination of the molecular mechanism of action of topical allogeneic ADSC therapy in the treatment of ulcers in patients with neuropathic diabetic foot. RESEARCH DESIGN AND METHODS: We examined a total of 57 patients with neuropathic diabetic foot in grades IA and IIA according to the University of Texas classification. Finally 23 patients received treatment with standard therapy and fibrin glue (fibrin gel group) and 23 received treatment with standard therapy and ADSC suspended in tissue glue (fibrin gel + ADSC group). The primary outcome was determining the time needed to reduce the wound size by 50% from the initial size in both groups by assessing the wound surface, the evaluation of treatment safety, expressed as the occurrence of any adverse events; the evaluation of symptoms improvement (e.g. pain, itching, etc.) assessed by Visual Analogue Scale (VAS) and analysis of the expression of selected pro-angiogenic and immunomodulatory factors in the wounds treated in both study groups. RESULTS:The ADSC group benefited from the use of stem cells in terms of accelerated wound healing and greater likelihood of complete healing of the wound. In a second week after administration of therapy, the difference between the groups was already statistically significant (p = 0,04). The time to the 50% reduction of the size of the wound in the fibrin gel + ADSC group was significantly shorter (18.9 +/- 2.2 days ) than in the group receiving fibrin gel (39.8 +/- 6.9 days ), p = 0.0035. CONCLUSIONS: The results of the preliminary analysis show that the use of allogeneic ADSCs in the treatment of neuropathic diabetic foot ulcers is a safe method of therapy, which allows to improve the effects of wound healing. Our study indicates also the association of higher expression of selected proteins expression intensifying the healing process through a faster transition to the proliferation phase with a faster reduction in wound area, and long-term efficacy of allogeneic ADSC cells.

Dataset Information

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

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