Autores: Jorge Berlanga Acosta, William Savigne, Calixto Valdez, Neobalis Franco, Jose SAlba, Amaurys del Rio, Pedro López-Saura, GerardoGuillén, Ernesto Lopez, Luís Herrera y José Fernández-Montequín.
Abstract
This study examined if a series of epidermal growth factor (EGF) local infiltrations can enhance the healing process of complicated diabetic wounds. Twenty-nine in-hospital patients with diabetic neuropathic or ischaemic lesions with high risk of amputation were treated in a non controlled pilot study conducted at the National Institute of Angiology, Havana. Lesions, classified as Wagner’s grade 3 or 4, included ulcers ≥ 20 cm2 for ≥ 25 days or amputation residual bases ≥ 30 cm2 for ≥ 15 days, healing refractory despite comprehensive wound care. EGF (25 mg) intralesional infiltrations (≈250 ml of a 25 mg/ml solution/injection point) were performed thrice weekly up to the eighth week. Wound closure was monitored during the treatment and recurrence examined for a year following discharge from hospital. Eighty-six per cent of the patients treated showed a productive granulation at infiltration session 8. Histological examination at this point indicated a substantial wound matrix transformation, granulation tissue cell repopulation and angiogenesis. Of the 29 patients treated, amputation was prevented in 17 (58.6%) of them who completed 24 infiltration sessions. They averaged 71.1 ± 18.3% of reepithelisation during a mean in-hospital period of 66.5 ± 4.9 days. Wound recurrence after 1 year of follow-up appeared in only one patient. Preliminary evidences suggest that EGF intralesional infiltrations may be effective in reducing diabetic lower limb amputation.
Autores: Jose Fernandez-Montequín, Blas Y Betancourt, Gisselle Leyva-Gonzalez, Ernesto Lopez Mola, Katia Galan-Naranjo, Mayte Ramírez-Navas, Sergio Bermudez-Rojas, Felix Rosales, Elizeth García - Iglesias, Jorge Berlanga-Acosta, Ricardo Silva-Rodriguez, Marianela Garcia-Siverio, Luis Herrera Martinez
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 mg 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.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 mg 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.
Autores: 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, for the Cuban Citoprot-P Study Group.
Abstract
Aim: To investigate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) in advanced diabetic foot ulcers (DFU).
Methods: A double-blind trial was done to test two rhEGF dose levels in type 1 or 2 diabetes patients with Wagner’s grade 3 or 4 ulcers. Subjects were randomised to receive 75 (group I) or 25 μg (group II) rhEGF through intralesional injections, 3 times per week for 5 to 8 weeks together with standardized good wound care. Endpoints were granulation tissue formation, complete healing and need of amputation. Safety was assessed by clinical adverse events (AEs) and laboratory evaluations.
Results: Forty-one patients were included. After 5 to 8 weeks of treatment 83% of the patients in the higher dose group and 61% in group II achieved useful granulation tissue covering more than 98% of the wound area. At long-term assessment 13 (56.5%) patients healed in group I and 9 (50%) in group II. The mean time to complete healing in group I was 20.6 weeks (95% CI 17.0 – 24.2) and 19.5 weeks (16.3 – 22.7) in group II. After one year follow-up only one patient relapsed. Amputation was not necessary in 65% and 66.7% of groups I and II, respectively. The adverse events rates were similar. The most frequent were sepsis (33%), burning sensation (29%), and tremors, chills and local pain (25% each).
Conclusions: rhEGFlocal injection enhances advanced diabetic foot ulcer healing and reduces the risk of major amputation. No dose-dependency was observed.
1960
Stanley Cohen (Premio Nobel de Medicina en 1986) inagura una nueva era en la Biología Celular y la medicina al descubrir el FCE.
“…observamos que cuando inyectamos preparados de glándulas submaxilares crudos en ratones recién nacidos,ocurrían una serie de efectos adversos inesperados. Esto es : apertura prematura de párpados (6-7 días comparado vs. 12-14 en la rama control) y una erupción precoz de los dientes (5-6 días , comparado con 8-10 en la rama control)…”
Stanley Cohen, Nobel Lecture December 8, 1986