Any of these conditions can increase the risk of suffering a diabetic foot ulcer and before the slightest trauma or injury, it is difficult to heal.
The treatment with Heberprot-P has benefited about 290 000 patients in twenty countries demonstrates the possibility of a cure for the healing of complex wounds, ischemic ulcers and those resulting from the diabetic foot, which increases the frequency of formation of effective granulation in the lesions treated and therefore, reduces the risk of amputation.
The drug, developed by the Center for Genetic Engineering and Biotechnology (CIGB) of Cuba, contains as an active pharmaceutical ingredient recombinant human epidermal growth factor, a peptide of 53 amino acids that when coupled to its receptor activates anabolic metabolism, promoting synthesis of amino acids and proteins, resulting in cell division.
Heberprot P is considered unique and first in its class. It is administered directly in the diabetic ulcerated tissues, generating an accelerated granulation of the lesions. Its basic principles are based on research conducted by the American scientist Stanley Cohen in the 60s from observing the behavior in many species of animals lick the wounds, applying abundant saliva in the openings of the skin, a feature that humans also do , especially when your fingers are injured by burns or cuts.
From 2001 to 2005, clinical trials II and III were initiated and concluded in different centers of the national health system. In these scenarios it was achieved that about 86% of people with complex diabetic lesions to which Heberprot were applied, did not suffer from amputations.
1. Treatment with Heberprot P accelerates the healing of deep and complex ulcers, therefore it can be used in ischemic and neuropathic ulcers larger than 20 centimeters.
2. It is the only one of its kind in the world, since treatments similar to this are provided topically and directed to lesions not exceeding 5 centimeters.
3. Reduce the risk of amputation in patients with diabetic foot ulcer.
4. It increases the quality of life of patients in Cuba and other countries since to date it is registered in 23 nations.
5. This treatment is the only one that has shown efficacy for diabetic foot ulcers in grade 3 and 4 according to the Wagner scale, since other traditional methods on the market do not respond to ischemic ulcers or those greater than 20 square centimeters.
6. The results of Heberprot P are successful in eight (8) types of lesions in patients with diabetic foot ulcers
1. This drug is contraindicated in patients with a history of hypersensitivity to the product or any of its components.
2. In people who suffer from decompensated heart disease, diabetic coma or diabetic ketoacidosis.
3. In addition to other patients with current diagnosis of oncological pathologies, history or suspicion of the existence of any type of neoplasia.
Treatment with Hebrprot P for diabetic foot ulcers consists of administering the same at a rate of 75 ?g, diluted in 5 mL of water for injection, three times a week, perilesionally and intralesionally. The administrations of HEBERPROT-P will be maintained until complete granulation of the lesion is achieved, closure of the lesion by grafting or a maximum of 8 weeks of treatment is reached. It is an injectable drug presented in the form of lyophilisate in glass bulbs, administered parenterally, intralesionally and perilesionally. (only under facultative prescription and used with specialized personnel)
Its packaging contains 6R glass bulbs of light neutral borosilicate grade hydrolytic class I¬, with a capacity of 5 mL, it has as an active ingredient the recombinant human Epidermal Growth Factor (FCEhrec); Bromobutyl stopper and flip-top cap.
The treatment with HEBERPROT-P is applied to individuals of any age, sex and race diagnosed with diabetes mellitus regardless of the type of diabetes they present and the time of evolution of the disease.
In the patients enrolled in the program we observed a reduction in the amputation rate of less than five percent.
|Componentes||Cantidad mg/5 mL de agua|
|Recombinant human growth factor(FCEhrec)||0,075 µg ó 0.025 µg|
|Dextran 40||5,000 mg|
|Sodium hydrogen phosphate||0,454 mg|
|Sodium dihydrogen phosphate dihydrate||1,061 mg|
|Water for injection||5 mL|