Introduction: Diabetic foot ulcers are a major source of morbidity and preventable amputations in sub-Saharan Africa, where therapeutic options remain limited. Oxygen-ozone therapy, with its effects on microcirculation, inflammation, and tissue repair, offers a promising adjuvant approach. This study aims to evaluate its clinical efficacy and tolerance in patients managed at the Centre Médical des S?urs Filles de Saint Camille (CMFISAC). Methods: A prospective observational study was conducted at CMFISAC (August-November 2024) enrolling twelve adults with type 2 diabetes and Wagner grade-1 DFU. Baseline evaluation included a full clinical examination, Doppler assessment, planimetry, and laboratory tests. Patients received twice-weekly ozone bagging (30 μg/mL, 20 min) plus L-Mesitran?. Healing was monitored through ulcer area reduction, granulation, pain, and infection control, using standardized photography and ImageJ-based quantitative analysis. ResultsandDiscussion: Ozone therapy produced consistent improvement: ulcer area decreased by 71% by day 35, with early granulation (days 12 - 15), progressive epithelialization, reduced inflammation, and 60% - 80% pain reduction. Photographs confirmed rapid tissue restoration. No adverse effects occurred. These outcomes align with ozone’s known antioxidant and anti-inflammatory mechanisms and mirror findings from international trials, supporting its promise as a safe, low-cost adjuvant for early-stage diabetic foot ulcers. Conclusion: Medical ozone therapy appears to be a safe, low-cost, and effective adjuvant for enhancing granulation and epithelialization in diabetic foot ulcers. Larger multicenter randomized trials remain necessary to confirm its benefits and establish standardized dosing protocols.
References
[1]
Huang, P.L. (2009) A Comprehensive Definition for Metabolic Syndrome. DiseaseModels&Mechanisms, 2, 231-237. https://doi.org/10.1242/dmm.001180
[2]
Cissé, K., Samadoulougou, D.R.S., Bognini, J.D., Kangoye, T.D. and Kirakoya-Samadoulougou, F. (2021) Using the First Nationwide Survey on Non-Communicable Disease Risk Factors and Different Definitions to Evaluate the Prevalence of Metabolic Syndrome in Burkina Faso. PLOSONE, 16, e0255575. https://doi.org/10.1371/journal.pone.0255575
Sagna, Y., Yanogo, D.A., Tiéno, H., Guira, O., Bagbila, A.P., Bognounou, R., etal. (2014) Obesity and Metabolic Syndrome in a Burkina Faso Urban Area: Prevalence, Associated Factors and Comorbidities. JournalofNutritionalDisorders&Therapy, 4, Article ID: 1000141. https://doi.org/10.4172/2161-0509.1000141
[5]
Genitsaridi, I., Salpea, P., Salim, A., Sajjadi, S.F., Tomic, D., James, S., etal. (2024) IDF Diabetes Atlas: Global, Regional and National Diabetes Prevalence Estimates for 2024 and Projections for 2050.
[6]
Armstrong, D.G., Boulton, A.J.M. and Bus, S.A. (2017) Diabetic Foot Ulcers and Their Recurrence. NewEnglandJournalofMedicine, 376, 2367-2375. https://doi.org/10.1056/nejmra1615439
[7]
Zhang, Y., Lazzarini, P.A., McPhail, S.M., van Netten, J.J., Armstrong, D.G. and Pacella, R.E. (2020) Global Disability Burdens of Diabetes-Related Lower-Extremity Complications in 1990 and 2016. DiabetesCare, 43, 964-974. https://doi.org/10.2337/dc19-1614
[8]
Zhang, P., Lu, J., Jing, Y., Tang, S., Zhu, D. and Bi, Y. (2016) Global Epidemiology of Diabetic Foot Ulceration: A Systematic Review and Meta-Analysis. AnnalsofMedicine, 49, 106-116. https://doi.org/10.1080/07853890.2016.1231932
[9]
Harding, J.L., Pavkov, M.E., Magliano, D.J., Shaw, J.E. and Gregg, E.W. (2018) Global Trends in Diabetes Complications: A Review of Current Evidence. Diabetologia, 62, 3-16. https://doi.org/10.1007/s00125-018-4711-2
[10]
Lipsky, B.A., Senneville, É., Abbas, Z.G., Aragón‐Sánchez, J., Diggle, M., Embil, J.M., etal. (2020) Guidelines on the Diagnosis and Treatment of Foot Infection in Persons with Diabetes (IWGDF 2019 Update). Diabetes/MetabolismResearchandReviews, 36, e3280. https://doi.org/10.1002/dmrr.3280
[11]
Boulton, A., Armstrong, D., Krisner, R., Attinger, C., Lavery, L., Lipsky, B., etal. (2018) Diagnosis and Management of Diabetic Foot Complications. ADAClinicalCompendia, 2018, 1-20. https://doi.org/10.2337/db20182-1
[12]
Abbas, Z. and Archibals, L. (2007) The Diabetic Foot in Sub-Saharan Africa: A New Management Paradigm. DiabeticFoot, 10, 128-136.
[13]
Abbas, Z.G. and Archibald, L.K. (2005) Tropical Diabetic Hand Syndrome: Epidemiology, Patho-Genesis, and Management. AmericanJournalofClinicalDermatology, 6, 21-28. https://doi.org/10.2165/00128071-200506010-00003
[14]
Carter, M.J., Frykberg, R.G., Oropallo, A., Sen, C.K., Armstrong, D.G., Nair, H.K.R., etal. (2023) Efficacy of Topical Wound Oxygen Therapy in Healing Chronic Diabetic Foot Ulcers: Systematic Review and Meta-Analysis. AdvancesinWoundCare, 12, 177-186. https://doi.org/10.1089/wound.2022.0041
[15]
Everett, E. and Mathioudakis, N. (2018) Update on Management of Diabetic Foot Ulcers. AnnalsoftheNewYorkAcademyofSciences, 1411, 153-165. https://doi.org/10.1111/nyas.13569
[16]
Filho, M.L.e.S., Paggiaro, A.O., Fernandes de Carvalho, V. and Gemperli, R. (2024) Ozone Therapy as a Treatment for Diabetic Foot Ulcers: A Systematic Review and Meta-analysis. JournalofWoundCare, 33, 958-967. https://doi.org/10.12968/jowc.2022.0189
(2005) The Clinical Application of Ozonetherapy. In: Ozone, Springer, 97-226. https://doi.org/10.1007/1-4020-3140-8_10
[19]
Bertolotti, A., Izzo, A., Grigolato, P.G. and Iabichella, M.L. (2013) The Use of Ozone Therapy in Buruli Ulcer Had an Excellent Outcome. BMJCaseReports, 2013, bcr2012008249. https://doi.org/10.1136/bcr-2012-008249
[20]
WHO Headquarters, Geneva, Switzerland (2025) Second WHO Global Meeting on Skin-Related Neglected Tropical Diseases. Theme: “Integration to Achieve 2030 Targets”.
[21]
Sagai, M. and Bocci, V. (2011) Mechanisms of Action Involved in Ozone Therapy: Is Healing Induced via a Mild Oxidative Stress? MedicalGasResearch, 1, Article No. 29. https://doi.org/10.1186/2045-9912-1-29
[22]
Rowen, R.J. and Robins, H. (2019) Ozone Therapy for Complex Regional Pain Syndrome: Review and Case Report. CurrentPainandHeadacheReports, 23, Article No. 41. https://doi.org/10.1007/s11916-019-0776-y
[23]
Elvis, A. and Ekta, J. (2011) Ozone Therapy: A Clinical Review. JournalofNaturalScience, BiologyandMedicine, 2, 66-70. https://doi.org/10.4103/0976-9668.82319
[24]
Wen, Q., Liu, D., Wang, X., Zhang, Y., Fang, S., Qiu, X., etal. (2021) A Systematic Review of Ozone Therapy for Treating Chronically Refractory Wounds and Ulcers. InternationalWoundJournal, 19, 853-870. https://doi.org/10.1111/iwj.13687
[25]
Martins, P.C.A.S. (2020) The Effect of Ozone Therapy on the Treatment of Diabetic Foot Ulcers: A Review. OzoneTherapyGlobalJournal, 10, 257-271.
[26]
Hao, K., Tang, S., Xie, H., Li, X. and He, X. (2019) Application of Ozone Therapy in Interventional Medicine. JournalofInterventionalMedicine, 2, 8-11. https://doi.org/10.1016/j.jimed.2019.05.003
[27]
Falanga, V. (2005) Wound Healing and Its Impairment in the Diabetic Foot. TheLancet, 366, 1736-1743. https://doi.org/10.1016/s0140-6736(05)67700-8
[28]
Berlanga-Acosta, J., Schultz, G.S., López-Mola, E., Guillen-Nieto, G., García-Siverio, M. and Herrera-Martínez, L. (2013) Glucose Toxic Effects on Granulation Tissue Productive Cells: The Diabetics’ Impaired Healing. BioMedResearchInternational, 2013, Article ID: 256043. https://doi.org/10.1155/2013/256043
[29]
Gould, L., Abadir, P., Brem, H., Carter, M., Conner-Kerr, T., Davidson, J., etal. (2015) Chronic Wound Repair and Healing in Older Adults: Current Status and Future Research. WoundRepairandRegeneration, 23, 1-13. https://doi.org/10.1111/wrr.12245
[30]
Werdin, F., Tennenhaus, M., Schaller, H.E. and Rennekampff, H.O. (2009) Evidence-Based Management Strategies for Treatment of Chronic Wounds. Eplasty, 9, e19.
[31]
León Fernández, O.S., Oru, G.T., Viebahn-Hänsler, R., López Cabreja, G., Serrano Espinosa, I. and García Fernández, E. (2022) Medical Ozone Arrests Oxidative Damage Progression and Regulates Vasoactive Mediator Levels in Elderly Patients (60-70 Years) with Oxidative Etiology Diseases. FrontiersinPhysiology, 13, Article 1029805. https://doi.org/10.3389/fphys.2022.1029805
[32]
Scarlett, J.M., Rojas, J.M., Matsen, M.E., Kaiyala, K.J., Stefanovski, D., Bergman, R.N., etal. (2016) Central Injection of Fibroblast Growth Factor 1 Induces Sustained Remission of Diabetic Hyperglycemia in Rodents. NatureMedicine, 22, 800-806. https://doi.org/10.1038/nm.4101
[33]
Li, X., Xie, X., Lian, W., Shi, R., Han, S., Zhang, H., etal. (2018) Exosomes from Adipose-Derived Stem Cells Overexpressing Nrf2 Accelerate Cutaneous Wound Healing by Promoting Vascularization in a Diabetic Foot Ulcer Rat Model. Experimental&MolecularMedicine, 50, 1-14. https://doi.org/10.1038/s12276-018-0058-5
[34]
Ogut, E. (2025) Mechanisms and Therapeutic Potential of Ozone Therapy in Enhancing Vasculogenesis and Angiogenesis through Growth Factor Activation and Oxidative Signaling Pathways. DiscoverMedicine, 2, Article No. 240. https://doi.org/10.1007/s44337-025-00491-7
[35]
Fitzpatrick, E.M. (2020) The Effects of Aqueous Ozone on Normal Platelet Function and Growth Factor Release in Diabetics and Non-Diabetics. Ph.D. Thesis, Griffith University.
[36]
Giunta, R., Coppola, A., Luongo, C., Sammartino, A., Guastafierro, S., Grassia, A., etal. (2001) Ozonized Autohemotransfusion Improves Hemorheological Parameters and Oxygen Delivery to Tissues in Patients with Peripheral Occlusive Arterial Disease. AnnalsofHematology, 80, 745-748. https://doi.org/10.1007/s002770100377
[37]
Viebahn-Hänsler, R., León Fernández, O.S. and Fahmy, Z. (2016) Ozone in Medicine: Clinical Evaluation and Evidence Classification of the Systemic Ozone Applications, Major Autohemotherapy and Rectal Insufflation, According to the Requirements for Evidence-Based Medicine. Ozone: Science&Engineering, 38, 322-345. https://doi.org/10.1080/01919512.2016.1191992
[38]
Frykberg, R.G. and Banks, J. (2016) Management of Diabetic Foot Ulcers: A Review. FederalPractitioner, 33, 16-23.
[39]
Dabiri, G., Damstetter, E. and Phillips, T. (2016) Choosing a Wound Dressing Based on Common Wound Characteristics. AdvancesinWoundCare, 5, 32-41. https://doi.org/10.1089/wound.2014.0586
[40]
Frykberg, R.G. and Banks, J. (2015) Challenges in the Treatment of Chronic Wounds. AdvancesinWoundCare, 4, 560-582. https://doi.org/10.1089/wound.2015.0635
[41]
Rajbhandari, J., Fernandez, C.J., Agarwal, M., Yeap, B.X.Y. and Pappachan, J.M. (2021) Diabetic Heart Disease: A Clinical Update. WorldJournalofDiabetes, 12, 383-406. https://doi.org/10.4239/wjd.v12.i4.383
[42]
Mbanya, J.C.N., Motala, A.A., Sobngwi, E., Assah, F.K. and Enoru, S.T. (2010) Diabetes in Sub-Saharan Africa. TheLancet, 375, 2254-2266. https://doi.org/10.1016/s0140-6736(10)60550-8
[43]
Alavi, A., Sibbald, R.G., Mayer, D., Goodman, L., Botros, M., Armstrong, D.G., etal. (2014) Diabetic Foot Ulcers: Part II. Management. JournaloftheAmericanAcademyofDermatology, 70, 21.e1-21.e24. https://doi.org/10.1016/j.jaad.2013.07.048
[44]
Clavo, B., Santana-Rodríguez, N., Llontop, P., Gutiérrez, D., Suárez, G., López, L., etal. (2018) Ozone Therapy as Adjuvant for Cancer Treatment: Is Further Research Warranted? Evidence-BasedComplementaryandAlternativeMedicine, 2018, Article ID: 7931849. https://doi.org/10.1155/2018/7931849