Note: Descriptions are shown in the official language in which they were submitted.
WO93/1079S PCT/US91/08840
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TOPICAL EMOLLIENT FQR PREVENTION AN:D TREATMENT
OF CIRCULATORY INDU OE D LESIONS
CROSS REFERENCE TO RELATION APPLICATIONS
This application is a continuation in-part of application
Serial No. 07/417,239 filed October ~, 1990.
10BACKGROUND OF THE INVENTION
This invention relates generally to the art of medicine and
more particularly to the art of treatment of skin lesions, skin
ulcers, and other skin maladies, and the treatment of some
circulatory disorders, and as a delivery device for
transporting topically applied drugs through intact ~kin.
It has been known for many years that patients suffering
from diabetes, phlebitis, or other circulatory problems often
develop lesions or ulcers which are dif~icult to treat. The
affected tissu~ is often poorly nourished or has impaired
circulation ana the resulting lesions may heal slowly if at
all. Further, many diabetic patients suffer ~rom neuro~athy
which predisposes the patients to falls and subsequent injuries
which are slow to heal and subject to secondary infectionsO
Infected areas which fail to respond to traditional treatment
protocols o~ten become gangrenous and require amputation of the
affect2d limb.
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The treatment for such maladies has involved two gener~
strategies; One, an attempt to increase circulation to
affected tissue and secondly, to treat the lesions by the u2
of general antibiotics to prevent infection. For diabet~
patients in particular, insulin packs and insulin/transferr~
packs have been used in the treatment of diabetic gangrene
However, all of these methods have had only limited succesc
one difficulty in the treatment protocol is that many usef~-
medicines to treat skin circulatory disorders require ora~subcutaneous or other delivery systems because the biologica~
active molecules are unable to be effectively absorbed ~r
utilized through the skin. To date, transport of m~
medicines is unable to occur through the skin surfa~
Therefore, much room for improvement exists in the art.
SUMMARY OF T~E INVENTION
It is t~us an object of this invention to provide a no~
topical emollient which when applied to circulatory indu~
lesions promotes nourishment of the affected cells, there~
eliminating the source of the lesions.
It is a further object of this invention to provide a no~
process for the treatment of circulatory induced lesions.
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It is a further object of this invention to provide a novel
J emollient which facilitates the uptake of biologically active
molecules across the skin's surface.
It is a still further object of this invention to provide
5 a process where t~pically applied medications can be more
effectively utilizeà by the target tissues.
These as well as other objects are accomplished by a topical
emollient comprising of a combination of glucose and insulin.
Tha topical emollient is utili~ed in a process wherein the
10 mixture is applied to the affected surface for nourishment
thereof and promotion of healing.
DETAILED DESCRIPTION
In accordance witn this invention it has been surprisingly
found that a source of glucose and insulin, applied to a
15 lesion, promoted the healing of the affected surface. This is
surprising since it has here-t;o-fore been felt that insulin
would not pass through the skin surface. However, -n
accordance with this invention, it has been found that when
applied with a source of glucose, the insulin mixture provides
20 or stimulates nourishment to the affected area. Further, it
has been found that the aqueous glucose and insulin mixture
enhances the therapeutic benefits of other topically applied
medications.
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WO93/10795 PCT/US91/08840
By way of example, topical applications of hydrocortisone
cream, when applied according to the claimed invention, show
increased therapeutic benefits consistent with an enhanced
uptake or more efficient utilization of the absorbed drug. As
such, the claimed invention will enable faster healing and
lower concentrations of drugs to be topically applied to
affected areas. This will not only lower the cost of treatment
but may significantly reduce undesirable drug side effects.
As the effective drug concentration is lowered, dose-responsive
side effects will be lessened. In addition, drugs which may
not ordinarily be administered through the skin may become
candidates for topical administration via the claimed
process.
The critical minimum concentrations and ratios of glucose
and insulin for effective treatment have not been determined.
An effective insulin concentration, however, is believed to be
as low as .06 units/ml in a 2% glucose solution. Effective
treatment has been obtained with concentrations of insulin
ranging from .06 units/ml to 2.0 units/ml. Similarly, glucose
concentrations ranging from 2% to the highly concentrated
levels found in strained honey, have all been successfully
used.
It is likely that all the effective doses to date contained
an excess concentration of both insulin and glucose. Since the
insulin/glucose mixture is extremely safe as topically applied
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~W093/10795 2 1 ~ 1 1 6 ~3 PCT/US91/OB840
and relatively inexpensive, the critica:L lower limit of
! activity has not been determined. In addition, the minimum
effective concentrations of the clz -sd invention may vary
widely depending upon the age, gener~ aall:h, and the surface
integrity of the patient's skin.
The insulin/glucose emollient is kept cool and away from
strong light. Under these conditions, it has been found that
the emollient remains stable and effective for at least several
weeks. The emollient is topically applied to the affectecl area
by gloved hand on intact skin, keeping the skin moist for at
least 10 minutes and using a sterile gauze pad to apply the
solution to broken skin areas to keep affected area moist for
at least 10 minutes. Following the emollient, other topical
medications may be applied to the affected surface. However,
if desired, lt would be possible to combine the emollient with
other medication for a one-step application process.
The preferred insulin source is a mixture of 70 ~ NPH
insulin and 30 % regular insulin. This ratio provides both
long duration insulin (NPH) and a quicker response insulin
(regular) though successful results have been obtained when
both forms of insulin wer~ used individually.
Having generally set forth the invention the following
specific examples are given as an illustration thereof.
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WO93/10795 PCT/U~91/08840
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EXAMPLE 1
A male diabetic patient 53 years of age had open diabetic
lesions on one foot and ankle consist.ing of multiple
lesions having an area of one to one and one-half (1-1
1/2l square inches in various stages of skin break down.
The trial was conducted by applying three times a day a
topical ointment of 0.6 units/ml of regular insulin in
a 5% glucose solution. Within five days improvement of
the patients condition had occurred. The patient was
discharged from the hospital and instructed to continue
the application of the mixture.
EXAMPLE 2
An elderly diabetic male patient was homebound because
of diabetic neuropathy. The patient had a scalp ulcer
approximately one and one-half (1 1/2) inches in
diameter. The patient had been treated about two (2)
years with very little success. -The scalp ulcer was
treated with a mixture of 2.0 units/ml of NPH insulin in
a strained honey solution. This mixture was applied once
a day and within two (2) weeks the ulcer was healed.
EX~MPLE 3
A 61 year old female patient ~uffering with severe
varicose veins and phlebitis was treated with a 0.4
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units/ml of insulin (a combination of 70% NPH insulin and
- 30 % regular insulin) in a 2% glucose solution.
Prior to treatment the patient suffered almost constant pain
even early in the morning. This had been a constant problem
for thirty (30) years. The mixture was kept cool and
away from light and was applied to the legs and feet
three (3) times a day at meal time. After five (5) days
of treatment the patient was free of pain in the feet cmd
legs even at the end of the day. This was the first
comfort that the patient had in some thirty (30) years.
After fifteen (15) months there have been no symptoms of
phlebitis and there has been a slow but constant
reduction in the size of the varicosities.
lS EXAMPLE 4
A 38 year old female patient was suffering from a skin
rash on her wrist. One half of the affected rash area
was treated with a topical ointment of 0.5%
hydrocortisone cream. The other half of the rash was
treated with a mixture of 0.4 units/ml insulin (a
combination of 70% NPH insulin and 30% resular insulin)
and 2% glucose followed by an applicatio~ of 0.5%
hydrocortisone cream. A marked increase in the healing
and recovery of the affected area was noted in the
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portion of the rash treated with the
hydrocortisone/insulin/glucose mixture.
It is thus seen that the emollient and process of this
invention provide a topical emollient which prevents and
promotes healing of lesions and ulcers caused by circulatory
problems and increases the effectiveness of other topical
medicines applied in conjunction with the claimed invention.
Many variations are apparent to those of skill in the art from
a reading of the above description which is exemplary in
nature. Such variations are embodied within the spirit and
scope of this invention as measured by the following appended
claims.
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