Doerler Martin1), Eming Sabine2), Dissemond Joachim3), Stücker Markus1) 1) Department of Dermatology, Venereology and Allergology. Vein Centre of the Departments of Dermatology and Vascular Surgery, Ruhr-University Bochum, Bochum, GERMANY 2) Department of Dermatology, Venereology and Allergology, University of Cologne, Cologne, GERMANY 3) Department of Dermatology, Venereology and Allergology, University of Essen, Essen, GERMANY

1. Doerler Martin1), Eming Sabine2), Dissemond Joachim3), Stücker Markus1)
1) Department of Dermatology, Venereology and Allergology. Vein Centre of the Departments of Dermatology and Vascular Surgery, Ruhr-University Bochum, Bochum, GERMANY
2) Department of Dermatology, Venereology and Allergology, University of Cologne, Cologne, GERMANY
3) Department of Dermatology, Venereology and Allergology, University of Essen, Essen, GERMANY
A NOVEL EGF-CONTAINING WOUND DRESSING FOR THE TREATMENT
OF RECALCITRANT CHRONIC LEG ULCERS
Aim
Methods
Three specialized German wound centres included 33 patients (20
females, 13 males) with recalcitrant leg ulcers (31 venous, 1 arterial,
1 post-radiation) into this study. The novel EGF-containing wound
dressing* was applied three times within the first two weeks of the
study, while best practice conservative wound treatment was
continued. The EGF-containing wound dressing is based on a
dissolvable collagen-gel matrix. According to the manufacturer, EGF
is embedded into the collagen and released during dissolution within
24 to 36 hours. The patients were followed up 1, 2 and 3 months
after treatment to evaluate: a) the measured wound size (fig. 1), b)
the ease of application, c) the resorption of the dressing, and d) the
wound dressing by means of a scale ranging from 1-5 (1 = best, 5 =
worst).
The aim of our prospective, non-comparative study was the
evaluation of the efficacy, tolerability and safety of a novel wound
dressing containing epidermal growth factor (EGF) in a collagen-gel
matrix for the treatment of recalcitrant chronic leg ulcers.
Fig. 1: Venous leg ulcer before and after treatment with the EGF-
containing wound dressing. A: After the first application of the
EGF-containing wound dressing*. B: At follow-up 3.
A B
* NEODERM® (Ars Arthro, Ankara, TURKEY)

2. Doerler Martin1), Eming Sabine2), Dissemond Joachim3), Stücker Markus1)
1) Department of Dermatology, Venereology and Allergology. Vein Centre of the Departments of Dermatology and Vascular Surgery, Ruhr-University Bochum, Bochum, GERMANY
2) Department of Dermatology, Venereology and Allergology, University of Cologne, Cologne, GERMANY
3) Department of Dermatology, Venereology and Allergology, University of Essen, Essen, GERMANY
A NOVEL EGF-CONTAINING WOUND DRESSING FOR THE TREATMENT
OF RECALCITRANT CHRONIC LEG ULCERS
Fig. 2: The mean ulcer size decreased significantly from 37.36
qcm at baseline to 23.33 qcm at follow-up 3 (Wilcoxon-test:
p=0.022)
Results
The protocol was completed by 27/33 patients. The reasons for
discontinuation were: wound infection (n=2), pain (n=1) and
increased wound size (n=1). Two additional patients lost to
follow-up after 2 and 3 months. The majority of ulcers was
present for more than 5 years (42.9%) or between 1 and 5
years (42.9%) prior to inclusion.
At the end of the study, three ulcers were completely healed.
Overall, the mean wound surface decreased from 37.36 qcm to
23.33 qcm (-14.03 qcm), which was statistically significant
(Wilcoxon-test: p=0.022, fig. 2). The wound dressing was
evaluated as easy to apply (95.98 points on a scale from 0-100,
100 = very easy to apply) and resorbable (mean 97.39%, 100%
= complete resorption) by patients and wound care specialists.
The mean subjective evaluations of the novel wound dressing
were 2.17 for wound care specialists and 2.4 for the patients.
* NEODERM® (Ars Arthro, Ankara, TURKEY)

3. Doerler Martin1), Eming Sabine2), Dissemond Joachim3), Stücker Markus1)
1) Department of Dermatology, Venereology and Allergology. Vein Centre of the Departments of Dermatology and Vascular Surgery, Ruhr-University Bochum, Bochum, GERMANY
2) Department of Dermatology, Venereology and Allergology, University of Cologne, Cologne, GERMANY
3) Department of Dermatology, Venereology and Allergology, University of Essen, Essen, GERMANY
A NOVEL EGF-CONTAINING WOUND DRESSING FOR THE TREATMENT
OF RECALCITRANT CHRONIC LEG ULCERS
Conclusions
References
1. Steed DL, Goslen JB, Holloway GA, Malone JM, Bunt TJ, Webster MW.
Randomized prospective double-blind trial in healing chronic diabetic foot
ulcers. CT-102 activated platelet supernatant, topical versus placebo.
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2. Bhansali A, Venkatesh S, Dutta P, Dhillon MS, Das S, Agrawal A. Which is
the better option: recombinant human PDGF-BB 0.01% gel or standard
wound care, in diabetic neuropathic large plantar ulcers off-loaded by a
customized contact cast? Diabetes Res Clin Pract. 2009 Jan;83(1):e13-6.
3. Upton Z, Wallace HJ, Shooter GK, van Lonkhuyzen DR, Yeoh-Ellerton S,
Rayment EA, et al. Human pilot studies reveal the potential of a vitronectin:
growth factor complex as a treatment for chronic wounds. Int Wound J. 2011
Oct;8(5):522-32.
Our results demonstrate that the novel EGF-containing wound
dressing was generally well tolerated and safe. The reduction
of wound size needs to be confirmed in a randomised
controlled trial.
Discussion
Considering that the current study included patients with leg
ulcers which did not respond to previous best-practice treatment
options including skin grafts (in 28.6%), superficial vein surgery
(35.7%) or arterial reperfusion surgery (3.6%) and the extensively
long ulcer durations prior to inclusion, we conclude that the shown
decrease in wound surface is promising. Especially in patients
with chronic wounds and contraindications for surgical procedures
like skin grafts, topical EGF-therapy widens the therapeutic
spectrum. Positive results for the treatment of chronic wounds
with topical growth factors could be shown in multiple previous
studies. Accelerated healing was demonstrated for the application
of a cocktail containing several growth factors including EGF in
diabetic foot ulcers and PDGF-gel (1, 2). A more recent study
showed effective epithelialisation of venous leg ulcers using a
growth factor solution including EGF (3).
* NEODERM® (Ars Arthro, Ankara, TURKEY)