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Non-Commercial Use Only Veins and Lymphatics 2012; volume 1:e6 Ulcerated hemosiderinic three months previous to this therapy. Significant improvement in these injuries, Correspondence: Eugenio Brizzio and Alberto dyschromia and iron deposits with a reduction in the dimensions of the Lazarowski, San Martín 965, 1st floor (Zip code within lower limbs treated brown spot (9 of 9) at Day 90, and complete 1004) Buenos Aires, Argentina. with a topical application scarring with a closure time ranging from 15 Tel. +54.11.4311.5559. to 180 days (7 of 9) were observed. The use of E-mail: [email protected]; of biological chelator [email protected]; topical lactoferrin is a non-invasive therapeu- [email protected]; tic tool that favors clearance of hemosiderinic 1 2 [email protected] Eugenio Brizzio, Marcelo Castro, dyschromia and scarring of the ulcer. The 3 2 Marina Narbaitz, Natalia Borda, success of this study was not influenced Key words: ulcerated haemosiderinic dyschro- Claudio Carbia,2 Laura Correa,4 either by the hemochromatosis genetics or mia, liposomal Lactoferrin, scarring, hemo- Roberto Mengarelli,5 Amalia Merelli,2 the iron metabolism profile observed. siderin-ferritin. Valeria Brizzio,2 Maria Sosa,6 Acknowledgments: the authors would like to Biagio Biancardi,7 Alberto Lazarowski2 thank P. Girimonte for her assistance with the statistical analysis of the results. We also wish to Introduction thank the patients who made this study possible. 1International Group of Compression and Conference presentation: part of the present Argentina Medical Association, Buenos Chronic venous insufficiency (CVI) is one of study has been presented at the following con- 2 Aires, Argentina; Department of Clinical the most significant health problems in devel- gresses: i) XX Argentine Congress of Hematology, Biochemistry, Institute of oped countries. Though the pathogenesis of October 18-22, 2011, Mar Del Plata, Argentina Pathophysiology and Clinical (submitted to the Poster Section); ii) III World skin changes and venous ulcers is not com- Symposium of advances in Phlebology and Biochemistry, School of Pharmacy and pletely understood, they occur as a late conse- Lymphology, November 10-12, 2011, Buenos Biochemistry, University of Buenos Aires, quence of chronic ambulatory venous hyper- Aires, Argentina (awarded); iii) Latin American Argentina; 3Pathology Department - tension, caused by outflow obstruction and Congress of Angiology and Vascular Surgery, Hematology - National Academy of reflux due to superficial or deep venous valve Novemberonly 24th, 2011, Cartagena, Colombia. Medicine, Buenos Aires, Argentina; incompetence. Ethological theories including Received for publication: 26 July 2012. 4 fibrin cuffs or leukocyte entrapment by chron- Favaloro’s Foundation, Buenos Aires, Revision received: 19 September 2012. ic inflammation have been suggested.1 Argentina; 5Pontifical Catholic University Accepted for publication: 26 September 2012. Haemosiderinic dyschromia (HD) of CVI is of Argentina, Buenos Aires, Argentina; a pathological entity that features a brownuse 6Italian Hospital of Buenos Aires, This work is licensed under a Creative Commons colored spot resulting from the deposit of free Attribution 3.0 License (by-nc 3.0). Argentina; 7Faculty of Pharmacy, iron within leg tissues. Iron is a highly irrita- University of Naples, Italy tive element capable of stimulating free-radi- ©Copyright E. Brizzio et al., 2012 cal release and of causing leg ulcers, thus pro- Licensee PAGEPress, Italy ducing an ulcerated hemosiderinic dyschro- Veins and Lymphatics 2012; 1:e6 doi:10.4081/vl.2012.e6 mia (UHD). Since it has been recognized as a Abstract grade IV cause of skin dyschromia according to CEAP classification, and taking into The ulcerative haemosiderinic dyschromia account that these effects can be self-pro- dermal cells;5 therefore, iron accumulation in of chronic venous insufficiency is difficult to duced or generated by stimulation of melanin, the skin should be secondary to any mecha- heal and presents a high accumulation of there is an increasing interest in the role of nism that may increase iron deposits before iron. Lactoferrin, a potent natural iron chela- iron tissue deposits caused by chronic venous carrying out this exfoliation. Iron is thought to tor, could help to scar this ulcerative haemosi - disorders. According to this, a brown discol- be a co-factor or mediator of skin toxicity in a derinic dyschromia. The objective of this oration of the skin near the injury can be con- variety of pathological situations, including study was to determine whether the topical sidered to be a typical sign of venous disease. sunburn,6 porphyria cutanea tarda,7 inflamma- application of a liposomal gel with Lactoferrin It occurs when blood cells leak out of blood tion,8 and skin cancer,9 as well as in hereditary favors scarring/degradation of the brownNon-commercial col- vessels. The hemoglobin from red blood cells hemochromatosis (HH).10 It is important to ored spot typical of ulcerative haemosiderinic is broken down into hemosiderin that is then distinguish HD in CVI from hereditary HH dyschromia. Nine patients with severe chron- permanently stored within the tissues. This because individual differences could be genet- ic venous insufficiency and ulcerative can take place after a significant injury in the ically determined by genes related to HH haemosiderinic dyschromia (CEAP-C6), with leg and is often worsened by an underlying 11 a natural evolution of over 12 months, were venous problem.2,3 (H63D, S65C and C282Y). included in the study. Hemo chromatosis gene Since extravasated blood cells with hemo- Lactoferrin (LFR) is a glycoprotein belong- mutations were investigated. The levels of globin are phagocyted by tissue macrophages ing to the family of transferrins, capable of serum ferritin, transferrin saturation and called siderophages, the accumulation of binding to iron. Both human and bovine LFR blood cell counts were analyzed. The presence hemosiderin within the injury area is a char- show a wide antimicrobial spectrum, against of hemosiderin was investigated through acteristic feature of the disease, resulting in positive and negative Gram bacterias, and cer- periulcerous and ulcer fundus biopsies car- the brownish color of the skin.2 Furthermore, tain viruses and fungi.12 The studies on LFR ried out at baseline and 30 days after treat- urinary hemosiderin could be a biological have focused on its ability to chelate iron in ment with Lactoferrin. The severity of the marker for the clinical follow up of chronic cases of hemosiderinic iron accumulation injuries (CEAP classification) was evaluated venous insufficiency with haemosiderinic (ecchymosis, post sclerotherapy, CVI).12 The at the beginning of and throughout the whole dyschromia.4 results of recent studies indicate that it is a 3-month treatment period. No patient had Nearly 25% of absorbed iron is normally powerful regulator of dermal fibroblasts, and received compression treatment during the eliminated from the body by exfoliation of epi- that it promotes cutaneous wound healing; 13,14 [page 18] [Veins and Lymphatics 2012; 1:e6] Article however, this has been poorly researched. Exclusion criteria HD in case of venous ulcers, a visual scale of There is currently no efficient treatment for The main inclusion criteria were: i) pres- brown color was used to follow up treatment. HD and associated ulcer in patients with CVI. ence of occlusive arterial pathology with a Baseline and weekly controls were carried out. In a recent systematic survey and meta-analy- more than 0.8 arm/ankle index; ii) known We used an analogical visual arbitrary num- sis, eight randomized clinical trials were iden- allergies; iii) pregnancy; iv) life expectancy bered scale of brown (Figure 1) that allowed us tified comparing treatment with stockings and less than 12 months; v) severe diseases co- to build a follow-up chart and to identify any bandages. Five studies revealed an advantage existing simultaneously with venous patholo- improvement in HD. in the use of stockings over bandages, while gies, e.g. cardiac or mental disorders, renal or Wound size is a basic parameter used to three other assays showed no difference.15 hepatic insufficiencies, tumors, etc.; vi) symp- evaluate the success of treatment. The plani- Our aim was to study the effect of liposomat- tomatic peripheral neuropathy, e.g. diabetic metric Visitrak® Smith and Nephew device ed bovine Lactoferrin, locally applied on the neuropathy; vii) patients with motor disabili- (Smith and Nephew, Hull, UK) was used. surface of UHD, in 9 patients with long-lasting ties; viii) diabetes; ix) severe joint disease of Volume was obtained through perimeters evolution of refractory CVI, selected from our the ulcerated leg, besides the ankle stiffness measured at 4 segments of the leg: 12 cm from previous study,16 and to evaluate its potential caused by venous ulceration. hallux extremity, and 10, 20 and 30 cm from relation to the iron metabolism profile and the floor (Figure 2A and B).18-19 mutations of HH genes.17 Goniometry was measured using the model described by Cleusa Belczak (Figure 3). 20 Study design Materials and Methods Pain was measured at baseline and after This was a prospective controlled pilot study four weeks of treatment using the arbitrary numerical Likert scale from 1 to 5, where 1 performed on 9 selected patients with severe Patients and persistent UHD of CVI, carried out accord- Indicates the lowest intensity of pain and 5 the Nine patients were selected (3 males, 6 21 ing to the inclusion and exclusion criteria highest one. The quality of life questionnaire females); average age 63 years. A total of 10 described below. in chronic lower limb venous insufficiency ulcerated legs were studied (unilateral ulcers, All patients gave their signed individual con- (CIVIQ) was evaluated as previously n=8; bilateral ulcers, n=2). 22 sent to treatment with topical application of described. liposomated LFR and to undergo biopsy of two onlyVenous blood samples for determining lesions. There were three evaluation time Ecodoppler hematimetric parameters as well as molecular points: at 30, 90 and 180 days.
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