Intra-lesional injections of recombinant human epidermal growth factor promote granulation and healing in advanced diabetic foot ulcers: multicenter, randomised, placebo-controlled, double-blind study
| Autor: | Odalys González Díaz, Heriberto Artaza-Sanz, José I Fernández-Montequín, Carlos M Hernández-Cañete, Pedro Lopez-Saura, William Savigne, Carmen M Valenzuela-Silva, Fidel Rivero-Fernández, Natasha Sancho-Soutelo, Pablo Sánchez-Penton, Lourdes Morejón-Vega, Cecilio González-Benavides, Alberto Vázquez-Proenza, Arístides García-Herrera, Jorge Berlanga-Acosta |
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| Rok vydání: | 2009 |
| Předmět: |
Male
medicine.medical_specialty Recombinant Epidermal Growth Factor Dermatology Injections Intralesional Placebo Gastroenterology law.invention Double-Blind Method Randomized controlled trial law Internal medicine medicine Humans Adverse effect Aged Wound Healing Dose-Response Relationship Drug Epidermal Growth Factor business.industry Granulation tissue Original Articles Odds ratio Middle Aged medicine.disease Diabetic foot Diabetic Foot Recombinant Proteins Surgery Treatment Outcome medicine.anatomical_structure Granulation Tissue Female Wound healing business Follow-Up Studies |
| Zdroj: | Int Wound J |
| ISSN: | 1742-481X 1742-4801 |
| Popis: | Fernández‐Montequín JI, Valenzuela‐Silva CM, González Díaz O, Savigne W, Sancho‐Soutelo N, Rivero‐Fernández F, Sánchez‐Penton P, Morejón‐Vega L, Artaza‐Sanz H, García‐Herrera A, González‐Benavides C, Hernández‐Cañete CM, Vázquez‐Proenza A, Berlanga‐Acosta J, López‐Saura PA, for the Cuban Diabetic Foot Study Group. Intra‐lesional injections of recombinant human epidermal growth factor promote granulation and healing in advanced diabetic foot ulcers: multicenter, randomised, placebo‐controlled, double‐blind study. A multicenter, double‐blind, placebo‐controlled trial was carried out to evaluate the intra‐lesional infiltration of recombinant epidermal growth factor (EGF) in Wagner's grade 3 or 4 diabetic foot ulcers (DFUs). Subjects (149) were randomised to receive EGF (75 or 25 µg) or placebo, three times per week for 8 weeks and standard good wound care. The main endpoint was granulation tissue covering ≥ 50% of the ulcer at 2 weeks. It was achieved by 19/48 controls versus 44/53 in the 75 µg group [odds ratio (OR): 7·5; 95% confidence interval (CI): 2·9–18·9] and 34/48 in the 25 µg group (OR: 3·7; 1·6–8·7). Secondary outcome variables such as end‐of‐treatment complete granulation response (28/48 controls, 46/53 with 75 µg and 34/48 with 25 µg EGF), time‐to‐complete response (controls: 5 weeks; both EGF dose groups: 3 weeks), and wound closure after follow‐up (25/48 controls, 40/53 with 75 µg and 25/48 with 25 µg EGF) were also treatment dependent. Multivariate analyses yielded that they were significantly enhanced by 75 µg EGF treatment and neuropathic versus ischemic ulcers. Most adverse events were mild and no drug‐related severe adverse reactions were reported. It was concluded that recombinant human EGF (rhEGF) local injections offer a favourable risk–benefit balance in patients with advanced DFU. |
| Databáze: | OpenAIRE |
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