Here - EWMA 2013

POSTER: DRESSINGS
Poster: Diabetic Foot
P 252
A NOVEL MECHANISM OF ACTION IN TREATING DIABETIC FOOT ULCER –
Results OF PHASE I/II STUDY
Dr. Liora Braiman Wiksman 1 , Y. Sagiv 1 , E. Brener 1 , M. Ben Hamou 1 , R. Mandil Levin 1 ,
E. Braude 1 , L. Hummer 1 , Y. Alegranti 1 , K. Olshvang 1 , O. Storobinsky 1 , B. Vaisman 1
1 HealOr Ltd. (Rechovot, Israel).
Aim: A biopharmaceutical company, has developed a novel drug* consisting of a PKC
activator and a PKCα inhibitor, for the treatment of non-healing, chronic wounds. A
Phase I, open label, multi-center study was conducted to assess the safety and efficacy
of the drug on neuropathic DFUs. Primary objectives were safety and efficacy.
Secondary objectives were time to closure and rate of healing.
Methods: Subjects’ eligibility was assessed over a two-week screening period, during
which wounds had surgical debridement, standard dressing and weight offload. Subjects
whose ulcer had decreased by 30% or more were excluded from the study. Following
screening, enrolled patients were treated topically with the drug once daily. Patients’
ulcers were assessed weekly by a physician; weekly wound size planimetry was
performed by a wound measurement system** and ulcers photography was done three
times a week.
Results: 21 DFU patients were screened, of which 15 patients were enrolled to
treatment with the drug. No toxicity or drug-related adverse events were reported. All
treated wounds demonstrated a positive healing response with re-epithelialization,
granulation, tissue formation and dermal regeneration. Treatment with the drug resulted
in significant amount of wound closure. 10 patients had their wounds closed with mean
closure time of 6.6 weeks (3-12 weeks). In 8/10 patients, closure was associated to
more than 50% wound reduction at 4 weeks; No wounds recurrence was observed with
a follow up of more than a year.
Conclusion: In summary, the results indicate the drug to be an effective drug for the
treatment of DFUs, previously demonstrated inadequate response to standard of care.
*HO/03/03
** VisitrakTM
P 253
A SIMPLE IN VITRO MODEL FOR ASSESSMENT OF ADHERENCE OF
TEXTILE MATERIALS TO WOUND SURFACES
Poster: Dressings
Pavel Klein 1 , Zuzana Valentova 1 , Jana Matonohova 1 , Jiri Betak 2 , Jolana Scudlova 2 ,
Iva Podhorna 3 , Vladimir Velebny 4
1 Contipro Pharma, a.s. (Dolni Dobrouc, Czech Republic);
2 Contipro Biotech, s.r.o. (Dolni Dobrouc, Czech Republic);
3 Secondary School of Agriculture (Lanskroun, Czech Republic);
4 Contipro Group, a.s. (Dolni Dobrouc, Czech Republic).
Introduction: Removal of dressing which has adhered to a wound is a painful and
stressful procedure for patients. It is therefore desirable to introduce dressings causing
minimal trauma to the tissue and minimally impair healing.
Aim: To develop a simple in vitro model for prediction of adherence of textile materials to
the wound.
Methods: The material to be tested is placed on an agarose-gelatine gel layered with
commercial powdered plasma-derived product containing high amount of fibrinogen
which is used in meat industry for the cold set binding of fresh meat 1 . Adherence of the
textile material, i.e. tensile strenght necessary for its removal from the gel surface, is
measured using a tension tester.
Results: Among the 16 tested monolayer materials the lowest adhesion was observed
with perforated low density polyethylene foil 2 (LDPE; 25 µm-perforation, 30gsm). Nonwoven
polyester textile 3 (30gsm) adherence was four times stronger as compared with
LDPE.
Conclusions: The proposed in vitro model uses a standardized fibrin-based product as
a source of components of the coagulation cascade. Coagulation is triggered when the
product makes contact with the gel, which simulates the situation on wound surfaces.
Data obtained from repeated measurements of different textile materials showed that
this model is simple and inexpensive, and can be used for reliably predicting adherence
to wounds.
1) Fibrimex ® , Sonac, The Netherlands
2) Tredegar, USA
3) Novolin, Polytex, Czech Republic
EWMA 2013
COPENHAGEN
15-17 May · 2013
Danish Wound
Healing Society
155