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Intralesional administration of epidermal growth factor‐based formulation (Heberprot‐P) in chronic diabetic foot ulcer: treatment up to complete wound closure |
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| Authors: | José I Fernández‐Montequín Blas Y Betancourt Gisselle Leyva‐Gonzalez Ernesto L Mola Katia Galán‐Naranjo Mayte Ramírez‐Navas Sergio Bermúdez‐Rojas Felix Rosales Elizeth García‐Iglesias Jorge Berlanga‐Acosta Ricardo Silva‐Rodriguez Marianela Garcia‐Siverio Luis H Martinez |
| Affiliation: | 1. JI Fernández‐Montequín, National Institute for Angiology and Vascular Surgery, Havana, Cuba;2. BY Betancourt, Clinical Trials Division, Center for Biological Research, Havana, Cuba;3. G Leyva‐Gonzalez, Health Lodging ‘Manuel Fajardo’;4. EL Mola, Center for Genetic Engineering and Biotechnology, Havana, Cuba;5. K Galán‐Naranjo, Health Lodging ‘Manuel Fajardo’;6. M Ramírez‐Navas, Health Lodging ‘Manuel Fajardo’;7. S Bermúdez‐Rojas, ‘Hermanos Amejeiras’ University Hospital, Havana, Cuba;8. F Rosales, Health Lodging ‘Manuel Fajardo’;9. E García‐Iglesias, Clinical Trials Division, Center for Biological Research, Havana, Cuba;10. J Berlanga‐Acosta, Center for Genetic Engineering and Biotechnology, Havana, Cuba;11. R Silva‐Rodriguez, Center for Genetic Engineering and Biotechnology, Havana, Cuba;12. M Garcia‐Siverio, Center for Genetic Engineering and Biotechnology, Havana, Cuba;13. LH Martinez, Center for Genetic Engineering and Biotechnology, Havana, Cuba |
| Abstract: | Previous studies have shown that an epidermal growth factor‐based formulation (Heberprot‐P) can enhance granulation of high‐grade diabetic foot ulcers (DFU). The aim of this study was to explore the clinical effects of this administration up to complete wound closure. A pilot study in 20 diabetic patients with full‐thickness lower extremity ulcers of more than 4 weeks of evolution was performed. Mean ulcer size was 16·3 ± 21·3 cm2. Intralesional injections of 75 μg of Heberprot‐P three times per week were given up to complete wound healing. Full granulation response was achieved in all 20 patients in 23·6 ± 3·8 days. Complete wound closure was obtained in 17 (85%) cases in 44·3 ± 8·9 days. Amputation was not necessary in any case and only one relapse was notified. The most frequent adverse events were tremors, chills, pain and ardour at site of administration and local infection. The therapeutic scheme of intralesional Heberprot‐P administration up to complete closure can be safe and suitable to improve the therapeutic goal in terms of healing of chronic DFU. |
| Keywords: | Diabetic foot ulcers Epidermal growth factor Wound healing |