PMID- 17953679
OWN - NLM
STAT- MEDLINE
DCOM- 20080313
LR  - 20221207
IS  - 1742-481X (Electronic)
IS  - 1742-4801 (Print)
IS  - 1742-4801 (Linking)
VI  - 4
IP  - 4
DP  - 2007 Dec
TI  - Intralesional injections of Citoprot-P (recombinant human epidermal growth 
      factor) in advanced diabetic foot ulcers with risk of amputation.
PG  - 333-43
AB  - 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.
FAU - Fernandez-Montequin, Jose I
AU  - Fernandez-Montequin JI
AD  - Service of Diabetic Microangiopathy, National Institute for Angiology and 
      Vascular Surgery, Havana, Cuba.
FAU - Infante-Cristia, Ena
AU  - Infante-Cristia E
FAU - Valenzuela-Silva, Carmen
AU  - Valenzuela-Silva C
FAU - Franco-Perez, Neobalis
AU  - Franco-Perez N
FAU - Savigne-Gutierrez, William
AU  - Savigne-Gutierrez W
FAU - Artaza-Sanz, Heriberto
AU  - Artaza-Sanz H
FAU - Morejon-Vega, Lourdes
AU  - Morejon-Vega L
FAU - Gonzalez-Benavides, Cecilio
AU  - Gonzalez-Benavides C
FAU - Eliseo-Musenden, Osvaldo
AU  - Eliseo-Musenden O
FAU - Garcia-Iglesias, Elizeth
AU  - Garcia-Iglesias E
FAU - Berlanga-Acosta, Jorge
AU  - Berlanga-Acosta J
FAU - Silva-Rodriguez, Ricardo
AU  - Silva-Rodriguez R
FAU - Betancourt, Blas Y
AU  - Betancourt BY
FAU - Lopez-Saura, Pedro A
AU  - Lopez-Saura PA
CN  - Cuban Citoprot-P Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20071022
PL  - England
TA  - Int Wound J
JT  - International wound journal
JID - 101230907
RN  - 62229-50-9 (Epidermal Growth Factor)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Amputation, Surgical/statistics & numerical data
MH  - Analysis of Variance
MH  - Diabetes Mellitus, Type 1/complications
MH  - Diabetes Mellitus, Type 2/complications
MH  - Diabetic Foot/*drug therapy/etiology/*surgery
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Epidermal Growth Factor/*administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - Granulation Tissue/drug effects
MH  - Humans
MH  - Injections, Intralesional
MH  - Male
MH  - Middle Aged
MH  - Probability
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Statistics, Nonparametric
MH  - Treatment Outcome
MH  - Wound Healing/*drug effects
PMC - PMC7951380
EDAT- 2007/10/24 09:00
MHDA- 2008/03/14 09:00
PMCR- 2007/10/22
CRDT- 2007/10/24 09:00
PHST- 2007/10/24 09:00 [pubmed]
PHST- 2008/03/14 09:00 [medline]
PHST- 2007/10/24 09:00 [entrez]
PHST- 2007/10/22 00:00 [pmc-release]
AID - IWJ344 [pii]
AID - 10.1111/j.1742-481X.2007.00344.x [doi]
PST - ppublish
SO  - Int Wound J. 2007 Dec;4(4):333-43. doi: 10.1111/j.1742-481X.2007.00344.x. Epub 
      2007 Oct 22.