Document Detail

Intralesional injections of Citoprot-P (recombinant human epidermal growth factor) in advanced diabetic foot ulcers with risk of amputation.
MedLine Citation:
PMID:  17953679     Owner:  NLM     Status:  MEDLINE    
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 (group I) or 25 mug (group II) rhEGF through intralesional injections, three times per week for 5-8 weeks together with standardised 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. Forty-one patients were included. 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 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 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 local injection enhances advanced DFU healing and reduces the risk of major amputation. No dose dependency was observed.
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;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-10-22
Journal Detail:
Title:  International wound journal     Volume:  4     ISSN:  1742-481X     ISO Abbreviation:  -     Publication Date:  2007 Dec 
Date Detail:
Created Date:  2007-12-24     Completed Date:  2008-03-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101230907     Medline TA:  Int Wound J     Country:  England    
Other Details:
Languages:  eng     Pagination:  333-43     Citation Subset:  IM    
Service of Diabetic Microangiopathy, National Institute for Angiology and Vascular Surgery, Havana, Cuba.
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MeSH Terms
Amputation / statistics & numerical data
Analysis of Variance
Diabetes Mellitus, Type 1 / complications
Diabetes Mellitus, Type 2 / complications
Diabetic Foot / drug therapy*,  etiology,  surgery*
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Epidermal Growth Factor / administration & dosage*
Follow-Up Studies
Granulation Tissue / drug effects
Injections, Intralesional
Middle Aged
Risk Assessment
Severity of Illness Index
Statistics, Nonparametric
Treatment Outcome
Wound Healing / drug effects*
Reg. No./Substance:
62229-50-9/Epidermal Growth Factor

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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