Diabetes Mellitus

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Diabetes mellitus (DM) is a disorder in which blood sugar (glucose) levels are abnormally high, because the body does not produce enough insulin to meet its needs, which is known as hyperglycemia, the main hindrance for wound healing in diabetic patients. In diabetic patients, urination and thirst are increased, and people lose weight when they are not trying to. DM damages nerves, and causes problems with sensation. In addition, DM damages blood vessels and increases the risk of heart attack, stroke, and kidney failure (see Table). It has been estimated an incidence of 350 000 people with DM in Cuba and more than 180 millions world wide.

Long-term complications of Diabetes mellitus.

 Tissue, organ affected  What happens?  Complications
Blood vessels Fatty material (atherosclerotic plaque) builds up and blocks large or medium-sized arteries in the heart, brain, legs, and penis. The walls of small blood vessels are damaged so that the vessels do not transfer oxygen to tissues normally, and the vessels may leak. Poor circulation causes wounds to heal poorly and can lead to heart disorders, strokes, gangrene of the feet and hands, erectile dysfunction (impotence), and infections.
Eyes The small blood vessels of the retina are damaged. Decreased vision and, ultimately, blindness occurs.
Kidney Blood vessels in the kidney thicken. Protein leaks into urine.Blood is not filtered normally. The kidneys malfunction, and ultimately, kidney failure occurs.
Nerves Nerves are damaged, because glucose is not metabolized normally and because the blood supply is not suitable. Legs suddenly or gradually weaken. People have reduced sensation, tingling, and pain in their hands and feet.
Autonomic nervous system The nerves that control blood pressure and digestive processes are damaged. Swings in blood pressure occur.Swallowing becomes difficult. Digestive function is altered, and sometimes bouts of diarrhea occur. Erectile dysfunction develops.
Skin Blood flow to the skin is reduced, and sensation is decreased, resulting in repeated injury. Sores and deep infections (diabetic ulcers) develop. Healing is poor.
Blood White blood cell function is impaired. People become more susceptible to infections, especially of the urinary tract and skin.
Connective tissue Glucose is not metabolized normally, causing tissues to thicken or contract. Carpal tunnel syndrome and Dupuytren's contracture develop.

Treatment of diabetes involves diet, exercise, education, and medication. If people with diabetes strictly control blood sugar levels, complications are less likely to develop. The goal of diabetes treatment, therefore, is to keep blood sugar levels within the normal range as much as possible. Treatment of high blood pressure and cholesterol levels can prevent some of the complications of diabetes as well. The Diabetes mellitus is a relative frequent disease now a day. The disease is divided in tow groups: non insulin-dependent Diabetes mellitus and insulin-dependent Diabetes mellitus. However, an early diagnosis of DM is currently possible due to the advances in the fields of medical sciences and technologies, which along with the treatment may delay and even prevent side effects caused by this disease.  

The world-wide incidence of DM was 171 million of people in 2000, and will reach 366 millions by the year 2030. A graze when walking, a small wound or nuisance in the diabetic can generate an ulcerous lesion, one of more common complications of the diabetic patients. DFU represents a significant source of morbidity and mortality in diabetic patients. Traditional treatments include removal of the necrotic tissue (debridement), revascularization, if possible, and antibiotic therapy. A great number of diabetic patients do not respond to such treatments, mainly if complications exist (infections, lack of arterial irrigation characteristic of the diabetic, and other health conditions) often resulting in patients susceptible to amputation. Nearly 50% of the amputated population can suffer from a second amputation of the counter-lateral extremity in a period 2 - 5 years, which involves the loss of the patients' quality of life, as well as considerable expenses for the health system (see Table). This problem is unfavorably exacerbated by the fact that less than 50% of amputated patients (major amputation) survive in the following 5 years, which makes it to become a world-wide urgent medical need. 

Costs of DFU per patient in relation to outcome (Euros).

Resource use Healed Unhealed Major amputation Unhealed (12 months)
Hospitalisation 2 647 4 771 10 953 8 907
Amputations 602 498 6 907 718
Revascularisation 538 238  624 734
Interventions 712 949 2 894 2 042
Diagnostic 126 104 289 345
Antibiotics 1060 959 1208 2120
Off-loading 449 165 360 636
Topical treatment 473 470 922 1780
Consultations 540 473 383 1508
Direct costs 7 147 8 628 24 540 18 790
Indirect costs 574 25 681 1275
Total 7 722 8 653 25 222 20 064

For example, in USA, the amount of diabetic patient reached 20 millions in 2005, and 84 000 amputations were performed. In Cuba, the diabetic population is near to 4,5%, it was estimated an incidence of 12 000 DFU/year, and 1 800 amputations/year, before Heberprot-P® was approved for commercialization. There is a growing interest in the use of growing factor for the treatment of DFU. A pharmaceutical composition containing the protein Platelet-derived growth factor (PDGF) has been approved for commercialization in USA and Europe for the topical treatment of DFU (Regranex), but it has shown to be useful only for DFU for small uncomplicated wounds with total areas lower than 5 cm2.

Patients treated

330 788

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