ArticleBMC pharmacology & toxicology2013
Active post-marketing surveillance of the intralesional administration of human recombinant epidermal growth factor in diabetic foot ulcers.
Article in BMC pharmacology & toxicology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- Growth factors for diabetic foot ulcers: mixed treatment comparison analysis of randomized clinical trials.British journal of clinical pharmacology · 2018Pooled it
- Growth factors for treating diabetic foot ulcers.The Cochrane database of systematic reviews · 2015Pooled it
- Epidermal Growth Factor Intralesional Delivery in Chronic Wounds: The Pioneer and Standalone Technique for Reversing Wound Chronicity and Promoting Sustainable Healing.International journal of molecular sciences · 2024Review
- Endogenous Biological Drivers in Diabetic Lower Limb Wounds Recurrence: Hypothetical Reflections.International journal of molecular sciences · 2023Review
- Economic optimization of expression of soluble human epidermal growth factor in Escherichia coli.Biotechnology letters · 2022Article
- Electrospun nanofibers as a wound dressing for treating diabetic foot ulcer.Asian journal of pharmaceutical sciences · 2019Review
- Healing enhancement of diabetic wounds by locally infiltrated epidermal growth factor is associated with systemic oxidative stress reduction.International wound journal · 2017Article
- Diabetic Foot Ulcers and Epidermal Growth Factor: Revisiting the Local Delivery Route for a Successful Outcome.BioMed research international · 2017Review
- Improved expression of recombinant plant-made hEGF.Plant cell reports · 2014Article
- Epidermal growth factor effect on lipopolysaccharide-induced inflammation in fibroblasts derived from diabetic foot ulcer.Scars, burns & healingArticle
- Intralesional Administration of Human Recombinant Epidermal Growth Factor Improves Healing and Reduces Amputations in Patients with Severe Diabetic Foot Ulcers.Current therapeutic research, clinical and experimentalArticle
- Curative Metatarsal Bone Surgery Combined with Intralesional Administration of Recombinant Human Epidermal Growth Factor in Diabetic Neuropathic Ulceration of the Forefoot: A Prospective, Open, Uncontrolled, Nonrandomized, Observational Study.Current therapeutic research, clinical and experimentalArticle
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAfter several exploratory and confirmatory clinical trials, the intralesional administration of human recombinant epidermal growth factor (hrEGF) has been approved for the treatment of advanced diabetic foot ulcers (DFU). The aim of this work was to evaluate the effectiveness and safety of this procedure in medical practice.
methodsA prospective, post-marketing active pharmacosurveillance was conducted in 41 hospitals and 19 primary care polyclinics. Patients with DFU received hrEGF, 25 or 75 μg, intralesionally 3 times per week until complete granulation of the ulcer or 8 weeks maximum, adjuvant to standard wound care. Outcomes measured were complete granulation, amputations, and adverse events (AE) during treatment; complete lesion re-epithelization and relapses in follow-up (median: 1.2; maximum 4.2 years).
resultsThe study included 1788 patients with 1835 DFU (81% Wagner's grades 3 or 4; 43% ischemic) treated from May 2007 to April 2010. Complete granulation was observed in 76% of the ulcers in 5 weeks (median). Ulcer non-ischemic etiology (OR: 3.6; 95% CI: 2.8-4.7) and age (1.02; 1.01-1.03, for each younger year) were the main variables with influence on this outcome. During treatment, 220 (12%) amputations (171 major) were required in 214 patients, mostly in ischemic or Wagner's grade 3 to 5 ulcers. Re-epithelization was documented in 61% of the 1659 followed-up cases; 5% relapsed per year. AE (4171) were reported in 47% of the subjects. Mild or moderate local pain and burning sensation, shivering and chills, were 87% of the events. Serious events, not related to treatment, occurred in 1.7% of the patients.
conclusionsThe favorable benefit/risk balance, confirms the beneficial clinical profile of intralesional hrEGF in the treatment of DFUs.
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