[0001] The present invention refers to a fabric with active principles and to a recharging
method of said principles having the main aim to prevent and/or to give the first
cures to the diabetic foot. Between the diabetes complications are known the problems
to the feet caused to ulcers, accidental injuries, micro-traumas, wounds also light,
callosity and infections. Are known the grave damages and the risks of grafting of
important complications from light wounds in the diabetic patient. The persons with
these pathologies have a reduced flux of blond in the inferior arts, in particular
from the knee to the foot, owing to a stricture of the arteries. Moreover, the diabetes
gives a progressive destruction of the nerves that arrive to the foot and to a skin
degeneration, that becomes dry and inflexible, so easy to be subjected to wounds.
The concomitance of these events determines infections often careless and minimal
realized to the diabetic patient, this due also to a minor sensibility of the nervous
terminations of the foot. The degenerative forms created to a light wound are, owing
to the complications given to the metabolic, circulatory and neurological alterations,
not to disregard as they easily evolve in serious pathologies, unfortunately favourite
to long times for healing the wounds in the diabetic patient, with consequent increasing
of risk of bacterial, viral and mycotic infections. The complications of a normal
disregarded ulceration are one of the more frequent causes of admission to hospital
for this pathology. The non-prevention and non-care of that known as diabetic foot
determines the claudication and, in the grave cases, the amputation of the art. A
consistent percentage of diabetic persons are subjected to ulcerations to the feet
that prolong in the time can grow worse. To have an idea of the problem are cited
the data of the Health World Organization where are counted in one hundred and twenty
million the diabetic persons in year 1996 and it is estimated in three hundred million
the number of diabetic persons in year 2025, where on an average the 15% will have
ulcerations to the feet with complications. Always from the cited sources are known
data that counted that for one hundred diabetic patients with amputations eighty-four
have had as cause of the amputation an ulceration to a foot grows worse in time. Moreover,
over the 50% of all the amputations of the lower limbs regards diabetic patients.
Currently are not known local preventive applications to be constantly used to prevent,
cure or reinforce the defences of the foot of the diabetic patient so to avoid the
complications previous described. The sole forms of prevention in this delicate sector
are given prevalently based onto mode of behaviour as the careful test of the food,
the sanitary education for observation of hygienic rules, the using of correct shoes
and the application of topical remedy at the appearing of the first ulcerations. The
invention, instead, realizes a therapeutic remedy able to prevent the formation of
ulcerations and to favourite the recovery of wounds eventually formed. The invention
creates a fabric, for specific application in this pathology, impregnated with substances
with synergetic action and gradual release, and a recharging method of said active
substances when these have lost their efficacy in time. The recharging of the active
principles to the fabric permits a reusing of the specific fabric and it permits to
have a set of clothes with controlled release of the active substances. The invention
consists of a fabric 1 in lycra fibres and micro-fibres (known with the trade "meryl"),
in variable percentages for application of this kind, that in actuation has the form
of stocking 2, pantyhose 3, sock 4, winding bandage with closed border 5, bandage
or plaster 6. This type of fabric, with new application for the specific pathology
of the diabetic foot, has the characteristic to have fibres with minor or equal subtlety
to ten micron. So the fibres of this fabric are of inferior diameter to that of the
silk, that have a subtlety of the fibres of twelve micron, of the cotton with subtlety
of the fibres of thirteen and half micron, of the cashmere with fibres diameter dimension
of fifteen micron and of the wool with fibres diameter dimension of seventeen micron.
The application of this characteristic of the invention is of big importance for the
diabetic foot such as more the thread is thin minor are the damages to abrasion of
the fabric onto the skin. So an extremely smooth fabric is obtained that no creates
micro-abrasions onto the inelastic skin and dry of the diabetic patient. In other
embodiment of the invention the fabric 1 is provided in the woof of thin silver yarns
7 with function anti-bacteric and bacteriostatic. To avoid grazes from sewing the
invention, in the form of the stocking 2, pantyhose 3, sock 4, has a sewing with flat
folding 8 in the anterior part of the stocking, imperceptible to the touch. The fabric
1, moreover, ha elastic property (elasticity of 99-100%) so to not obstruct the venous
flux, to not worsening the occlusive peripheral arterypatia and to favourite the local
microcirculation. Unlike to the other synthetic fibres, moreover, it has capacity
of umidity absorption, low rate of water retention and, differently to the natural
fibres, quick time of drying. These characteristic have like resulting capacity to
oppose the formation of fungus and to limit the bacteric growth. To the fabric 1 are
then added active substances with application method to the fabric and recharging
method of new conception. To the fabric 1 is bound a glycoprotein 9 (pseudoalteromonos
ferment extract, known with the trade "antarcticine") synthesized to a bacteria (pseudoalteromanas
antartica NF3) of the species Gram-negative, with composition of the fat acids and
to the proteinic outline typical of the alteromonas family. This substance during
the cellular growth produces a glycoprotein exopolymer composed of the 76-86% of proteins
and to 8-14% of sugar, in base of the used means. This active substance have had use,
previous to the invention, like a cosmetic humectant and emollient ingredient and
like a substance with crioprotective property. Said active principle, of new and original
application in the treatment of the diabetic foot, has important property that opposed
the dryness of the skin typical of the diabetic patient. It gives, infact, the coesion
between the spinous and germinativum stratum favouring the madding and the folding
of the interkeratociti liquids, so as estimated through the compression studies of
the isotherms and of the multilayer of the Langmuir balance. Moreover, said substance
stimulates the growth of the human skin fibroblast in the tests in vitro without the
growth of the keratinociti, so acting onto the micro-ulcerations of the skin to their
first turning up and onto all the cute surface, from the knee to the foot. Moreover,
the active principle given to the cited substance increases the formation of elastin
and of collagen type I and type IV with increasing of the cute hydration of at least
the 45% in the twelve subsequent hours in comparison with a sample of skin not treated
or treated with cream with the only placebo effect. This substance is inserted in
the wet fabric in a quantity of at least 1 mg/ml. To the fabric 1 is then added, without
order of insertion to the fabric but with modality of charge and recharge following
described, an exapeptide 10 from the alpha chain (known with trade "serilesine").
This peptide increases the adhesion of the cells, favours the cellular proliferation
and betters the microcirculation such as it favours the angiogenesis. This active
substance is added to the wet fabric 1 in quantity at least of 0,05 mg/ml. Also this
last substance is never previous used for the use in pathology such that of the diabetic
foot. Both these substances are previous used in the cosmetic field. So they do not
present toxicity problems and they are not to be considered drugs to be prescribed
with prescription. In particular they do not have, such the made tests has certified,
cytotoxicity on human fibroblasts, cytotoxicity on keratinocity, they have no given
toxicity prove in the tests of hemolysis, in the tests of genotoxicity, i.e. in the
Ames tests, and they are not irritating as valuing with the het-cam for the valuation
of the potential ocular irritation. The used substances in the described concentrations
do not create irritation to the skin, sensitization phenomenon, ocular irritation
and oral and skin toxicity. These substances 9 and 10 are moreover bound to the fabric
1 essentially for coulomb bond, being they with prevalent positive charge whereas
the fabric has fibres with negative charge for own constitution. The substances 9
and 10 are mixed into microcapsules 11 soluble in water. The fabric 1 is then washed
in water at 50°C. Ending this working the water is discharged and the fabric is wet
with clean water to which is added a mordanting assistant 12, the nylofixam PM (known
with trade "clariant") that has the function to bound the substances contained in
the microcapsules 11 to the aminic group of the fabric 1, by means of the polarization
that favours the union between the fabric 1 and the substances 9 and 10 into the microcapsules.
The fixer 12 is then added in proportion of 4% of the weight of the fabric 1 to treat.
Then are introduced in the bath the microcapsules 11 in the dose previous described
and in total quantity of the 6% of the weight of the fabric. After ten minutes is
added a cationic product 13, i.e. softenol 70 (known with trade "lautex") that contributes
also it to bound the microcapsules 11 with the fabric 1. The "lautex" is added in
percentage of 2% of the weight of the fabric. After ninety minutes the bath is let
out and the fabric 1 is centrifuged and dry, ready to be used. In the version for
the domestic use the microcapsules 11 and the fixers 12 and 13 to the fabric 1 are
sold in pre-dosed packaging, to can use the stocking 2, the pantyhose 3, the sock
4, the winding bandage 5, the bandage or plaster 6. To actuate the recharging of the
active substances 9 and 10 to the fabric 1 for domestic three grams of substances
9 and 10 in microcapsules 11 are brought and they are dissolved into 300-500 ml. of
water, after to have washed the used fabric 1, at a temperature inferior to 40°C.
The pantyhose, or the sock or the other forms of the fabric 1 are then left in soaking
for 15-20 minutes. These products are then dry in air. After this treatment the fabric
1 have an uniform distribution of the active principles. With pre-determined times
are provided rechargings, also conserving the active principles effectiveness till
the third days of use. The invented product conserves the active principles also after
three washings. However, it is suggested the daily washing and the recharging after
three days from the first use with the method above described. The simple application
of a cream with active principles does not reach the useful results for the diabetic
foot pathology such as the results obtained with the invention such as the friction
of the foot with the conventional pantyhose creates, during the walk, frictions that
take off the cream instead of makes it to absorb to the skin of the foot and neither
the occlusive bandages with cream and gauzes are not to be used if no with the patient
in bed. The invention is so to be used in the daily without constraints and/or changing
to the style of life of the patient. The invention in the application in the form
of application also winding bandage 5, cicatrizant bandage or plaster 6 have application
also remedy for the bedsores and/or light wounds.. The cicatrizant action, the better
of the micro-circulation and the effect on the derma determine a quick healing of
these woods without collateral effects. The invention is illustrated in a merely indicative
way in the drawings of sheets 1 and 2. In sheet 1 figure 1 is view of an example of
production like a stocking. In the same table 1 the figure 2 is view of an application
like a stock. Figure 3 is view of the version like a pantyhose. Figure 4 is view of
the version of winding bandage with closed profile. Figure 5 is view of the version
of bandage or plaster. In sheet 2 are illustrated some sequences of the recharging
phase of the active principles of the invention. In detail figure 6 is view of the
immersion phase. Figure 7 is view of the invention soaks in water with the active
principles.
