Treatment of Diabetic Foot Ulcers - Juniper Publishers
Journal of Trends in Technical and Scientific Research
Keywords
Keywords: Stigmatization; Social isolation; Medication; Surgical procedures; Amputation; Prosthesis; Rehabilitation
Abbreviations: DFU: Diabetic Foot Ulcer; IWGDF: International Working Group of the Diabetic Foot; LLA: Lower Limb Amputation
Opinion
Diabetic wound is the most common cause of
non-traumatic lower extremity amputation, and response to traditional
interventions is poor in many patients. The lifetime risk of developing
an ulcer among diabetics is 25%, and recurrent wounds are common after
healing. Stigmatization, social isolation, unemployment, and depression
are some of the negative consequence of Diabetic Foot Ulcer (DFU) on the
quality of life of diabetics. DFU adds a substantial economic burden to
afflicted patients and health systems, primarily attributable to
frequent hospitalization, medication, surgical procedures, amputation,
prosthesis, rehabilitation, and loss of productivity.
Fran Game points out key issues that put into
context advances on Research and Development (R&D) of medical
solutions for DFU [1].
This comment and systematic reviews by the International Working Group
of the Diabetic Foot (IWGDF) suggest that attention should also be paid
to more critical issues of the DFU’s global situation. First, R&D
productivity on DFU has been low for a long time, and most treatments
have been focused to low-grade, neuropathic ulcers, excluding highgrade
ulcers, which are more likely to progress to amputation. A comparison of
clinical trial data between 2012 and 2017 revealed a reduction in the
amount of molecules under investigation by 26, according to a manually
curated database.
Second, a relevant solution to treat advanced DFU
has been developed in a country without resources to meet requirements
of major regulatory agencies (FDA-EMA) [2].
This treatment has saved 3 600 people per year from Lower Limb
Amputation (LLA) in Cuba from 2006, and would save more in the other
countries, in case of regulatory approval. Health authorities from
Turkey, Slovakia, Ukraine, Georgia, Belarus, Kazakhstan, Russia, and
other countries have granted approval, after clinical trials, due
diligence, and inspection in situ of manufacturing facilities and
quality system, as a rational alternative to LLA [3].
On one hand, this medicine has been created in a
developing country, but it is not available for DFU patients in
developed nations, because obtaining regulatory approval would require
unaffordable investments [4-6].
On the other, this medicine has been approved for commercialization in
more than 20 countries, including several European territories, and one
member of the European Union. A direct conclusion could be that patients
from nations with the highest regulatory standards will probably have
not access to innovative medicines created in developing countries,
although being manufactured in compliance with current Good
Manufacturing Practices [79].
Other innovative medicines developed in Cuba have been facing this
challenge for more than 10 years, and a remarkable pipeline of more than
20 R&D biomedical projects point to that [10]. Therefore, it is not difficult to forecast a similar situation in other developing countries with less economic hindrances.
Diabetic wound is the most common cause of
non-traumatic lower extremity amputation, and response to traditional
interventions is poor in many patients. The lifetime risk of developing
an ulcer among diabetics is 25%, and recurrent wounds are common after
healing. Stigmatization, social isolation, unemployment, and depression
are some of the negative consequence of Diabetic Foot Ulcer (DFU) on the
quality of life of diabetics. DFU adds a substantial economic burden to
afflicted patients and health systems, primarily attributable to
frequent hospitalization, medication, surgical procedures, amputation,
prosthesis, rehabilitation, and loss of productivity.
Fran Game points out key issues that put into
context advances on Research and Development (R&D) of medical
solutions for DFU [1].
This comment and systematic reviews by the International Working Group
of the Diabetic Foot (IWGDF) suggest that attention should also be paid
to more critical issues of the DFU’s global situation. First, R&D
productivity on DFU has been low for a long time, and most treatments
have been focused to low-grade, neuropathic ulcers, excluding highgrade
ulcers, which are more likely to progress to amputation. A comparison of
clinical trial data between 2012 and 2017 revealed a reduction in the
amount of molecules under investigation by 26, according to a manually
curated database.
Second, a relevant solution to treat advanced DFU
has been developed in a country without resources to meet requirements
of major regulatory agencies (FDA-EMA) [2].
This treatment has saved 3 600 people per year from Lower Limb
Amputation (LLA) in Cuba from 2006, and would save more in the other
countries, in case of regulatory approval. Health authorities from
Turkey, Slovakia, Ukraine, Georgia, Belarus, Kazakhstan, Russia, and
other countries have granted approval, after clinical trials, due
diligence, and inspection in situ of manufacturing facilities and
quality system, as a rational alternative to LLA [3].
On one hand, this medicine has been created in a
developing country, but it is not available for DFU patients in
developed nations, because obtaining regulatory approval would require
unaffordable investments [4-6].
On the other, this medicine has been approved for commercialization in
more than 20 countries, including several European territories, and one
member of the European Union. A direct conclusion could be that patients
from nations with the highest regulatory standards will probably have
not access to innovative medicines created in developing countries,
although being manufactured in compliance with current Good
Manufacturing Practices [79].
Other innovative medicines developed in Cuba have been facing this
challenge for more than 10 years, and a remarkable pipeline of more than
20 R&D biomedical projects point to that [10]. Therefore, it is not difficult to forecast a similar situation in other developing countries with less economic hindrances.
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