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Updated: Sep 19, 2025

Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
Successful treatment of severe venous leg ulcers and diabetic foot ulcers using ozone
Giuseppe Masiello1, Marianno Franzini2, Umberto Tirelli3
1Division of Antalgic Therapy and Rehabilitation, Clinics Salus Fisiocenter, Capurso, Bari, Italy; Italian Scientific Society of Oxygen-Ozone Therapy (SIOOT) and High Master School of Oxygen-Ozone Therapy, University of Pavia, Pavia, Italy.
Background:
Venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) are chronic wounds associated with significant morbidity, high recurrence rates, and poor healing outcomes. Conventional treatments often fail to achieve satisfactory results, leading to prolonged pain, infection risks, and reduced quality of life. Oxygen-ozone therapy (OOT) has emerged as a potential adjunct to conventional wound care, with antimicrobial, anti-inflammatory, and tissue-regenerating properties. This study evaluates the efficacy of OOT in treating severe VLUs and DFUs.
Methods:
A total of 25 patients (mean age, 57.2 ± 10.51) with refractory VLUs (n = 18) or DFUs (n = 7) received OOT alongside standard care. Treatment protocols included major autohemotherapy (O2-O3-MAHT), topical ozone application, and localized ozone injections. Clinical assessments included pain scoring (Numeric Rating Scale), microbiological evaluations, and logistic regression analysis to determine healing rates.
Results:
At 4 weeks, pain scores decreased by 73.27% (P < .0001), and 92% of septic lesions showed negative bacterial cultures. Logistic regression analysis indicated a significant improvement in healing rates (P < .0001), with 80% of patients achieving complete wound closure. Inflammatory markers were reduced, and tissue regeneration was enhanced.
Conclusions:
OOT demonstrated substantial efficacy in reducing infection, alleviating pain, and promoting wound healing in patients with severe VLUs and DFUs, restoring their healthy, normal limbs. These findings support the use of OOT as a valuable adjunctive treatment. Further large-scale, randomized trials are needed to optimize treatment protocols and confirm long-term benefits.
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