OBJECTIVE: To study the healing effect of recombinant human epidermal growth factor (hEGF) on diabetic foot ulcers. RESEARCH DESIGN AND METHODS: A total of 127 consecutive patients were screened and 61 diabetic subjects were recruited into this double-blind randomized controlled study. Predetermined criteria were used for diagnosis and classification of the diabetic wound. The patients were randomized into three groups. All patients attended our Diabetes Ambulatory Care Center every other week for joint consultation with the diabetologist and the podiatrist. Group 1 (control) was treated with Actovegin 5% cream (Actovegin), group 2 with Actovegin plus 0.02% (wt/wt) hEGF, and group 3 with Actovegin plus 0.04% (wt/wt) hEGF. The study end point was the complete closure of the wound. Failure to heal was arbitrarily defined as incomplete healing after 12 weeks. RESULTS: Final data were obtained from 61 patients randomly assigned into three groups. The mean ages of the patients, wound sizes, wound duration, metabolic measurements, and comorbidities were comparable within groups, except that group 3 had more female patients. Mean follow-up for the patients was 24 weeks. Data were cutoff at 12 weeks, and results were analyzed by intention to treat. After 12 weeks, in group 1 (control) eight patients had complete healing, two patients underwent toe amputation, and nine had nonhealing ulcers. In group 2 (0.02% [wt/wt] hEGF) 12 patients experienced wound healing, 2 had toe amputations, and 7 had nonhealing ulcers. Some 20 of 21 patients in group 3 (0.04% [wt/wt] hEGF) showed complete wound healing. Healing rates were 42.10, 57.14, and 95% for the control, 0.02% (wt/wt) hEGF, and 0.04% (wt/wt) hEGF groups, respectively. Kaplan-Meier survival analysis suggested that application of cream with 0.04% (wt/wt) hEGF caused more ulcers to heal by 12 weeks and increased the rate of healing compared with the other treatments (log-rank test, P = 0.0003). CONCLUSIONS: Our data support the contention that application of hEGF-containing cream, in addition to good foot care from a multidisciplinary team, significantly enhances diabetic foot ulcer wound healing and reduces the healing time.
RCT Entities:
OBJECTIVE: To study the healing effect of recombinant humanepidermal growth factor (hEGF) on diabetic foot ulcers. RESEARCH DESIGN AND METHODS: A total of 127 consecutive patients were screened and 61 diabetic subjects were recruited into this double-blind randomized controlled study. Predetermined criteria were used for diagnosis and classification of the diabetic wound. The patients were randomized into three groups. All patients attended our Diabetes Ambulatory Care Center every other week for joint consultation with the diabetologist and the podiatrist. Group 1 (control) was treated with Actovegin 5% cream (Actovegin), group 2 with Actovegin plus 0.02% (wt/wt) hEGF, and group 3 with Actovegin plus 0.04% (wt/wt) hEGF. The study end point was the complete closure of the wound. Failure to heal was arbitrarily defined as incomplete healing after 12 weeks. RESULTS: Final data were obtained from 61 patients randomly assigned into three groups. The mean ages of the patients, wound sizes, wound duration, metabolic measurements, and comorbidities were comparable within groups, except that group 3 had more female patients. Mean follow-up for the patients was 24 weeks. Data were cutoff at 12 weeks, and results were analyzed by intention to treat. After 12 weeks, in group 1 (control) eight patients had complete healing, two patients underwent toe amputation, and nine had nonhealing ulcers. In group 2 (0.02% [wt/wt] hEGF) 12 patients experienced wound healing, 2 had toe amputations, and 7 had nonhealing ulcers. Some 20 of 21 patients in group 3 (0.04% [wt/wt] hEGF) showed complete wound healing. Healing rates were 42.10, 57.14, and 95% for the control, 0.02% (wt/wt) hEGF, and 0.04% (wt/wt) hEGF groups, respectively. Kaplan-Meier survival analysis suggested that application of cream with 0.04% (wt/wt) hEGF caused more ulcers to heal by 12 weeks and increased the rate of healing compared with the other treatments (log-rank test, P = 0.0003). CONCLUSIONS: Our data support the contention that application of hEGF-containing cream, in addition to good foot care from a multidisciplinary team, significantly enhances diabetic foot ulcer wound healing and reduces the healing time.
Authors: J J Heffner; J W Holmes; J P Ferrari; J Krontiris-Litowitz; H Marie; D L Fagan; J C Perko; H A Dorion Journal: Hernia Date: 2012-06-28 Impact factor: 4.739
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 Journal: Int Wound J Date: 2009-02 Impact factor: 3.315
Authors: José I Fernández-Montequín; Carmen M Valenzuela-Silva; Odalys González Díaz; William Savigne; Natasha Sancho-Soutelo; Fidel Rivero-Fernández; Pablo Sánchez-Penton; Lourdes Morejón-Vega; Heriberto Artaza-Sanz; Arístides García-Herrera; Cecilio González-Benavides; Carlos M Hernández-Cañete; Alberto Vázquez-Proenza; Jorge Berlanga-Acosta; Pedro A López-Saura Journal: Int Wound J Date: 2009-12 Impact factor: 3.315
Authors: José I Fernández-Montequín; Ena Infante-Cristiá; Carmen Valenzuela-Silva; Neobalis Franco-Pérez; William Savigne-Gutierrez; Heriberto Artaza-Sanz; Lourdes Morejón-Vega; Cecilio González-Benavides; Osvaldo Eliseo-Musenden; Elizeth García-Iglesias; Jorge Berlanga-Acosta; Ricardo Silva-Rodríguez; Blas Y Betancourt; Pedro A López-Saura Journal: Int Wound J Date: 2007-10-22 Impact factor: 3.315