PUBLICACIONES

Epidermal growth factor intralesional infiltrations can prevent amputations in patients with advanced diabetic foot wounds.
Berlanga Acosta, Jorge. et al., 2006. International Wound Journal 3(3):232-239.

Resumen
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 μg) intralesional infiltrations (≈250 μl of a 25 μg/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.

Intralesional Injections of Citoprot-P (recombinant Human Epidermal Growth Factor) in Advanced Diabetic Foot Ulcers with Risk of Amputation.
Fernández-Montequín José F. et al., 2007. International Wound Journal Dec;4(4):326-327.

Resumen
To investigate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) in advanced diabetic foot ulcers (DFU) A double-blind trial was carried out to test two rhEGF dose levels in type 1 or 2 diabetes patients with Wagner’s grade 3 or 4 ulcers, with high risk of amputation. Subjects were randomised to receive 75 roup I) or 25 μg (group II) rhEGF through intralesional injections, three times per week for 5–8 weeks together with standardised good wound care. Endpoints were anulation tissue formation, complete healing and need of amputation. Safety was assessed by clinical adverse events (AEs) and laboratory evaluations. Forty-one atients were cluded. After 5–8 weeks of treatment, 83% patients in the higher dose group and 61% in group II achieved useful granulation tissue covering more than 98% of the ound 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 0.6 weeks (95% CI: 17.0–24.2) and 19.5 weeks (16.3–22.7) in group II. After 1-year follow-up, only one patient relapsed. Amputation was not necessary in 65% and 66.7% of groups I and II, respectively. The AEs rates were similar. The most frequent were sepsis (33%), burning sensation (29%), tremors, chills and local pain (25% each). rhEGF calnjection enhances advanced DFU healing and reduces the risk of major amputation. No dose dependency was observed.