HEBERPROT-P Cuban Medicine for the treatment of Diabetic Foot Ulcer

Cuban treatment for diabetic foot ulcer

Heberprot-P: A revolutionary and hopeful therapy.  Heberprot-P is a novel and unique Cuban medicine prescribed for the therapy of diabetic foot ulcer (DFU) based on recombinant human growth factor (FCHrec.), By intralesional infiltration directly at the wound site.
 
Treatment with HEBERPROT-P Cuban drug for the treatment of Diabetic Foot Ulcer HEBERPROT-P fills the space with an unmet medical need for the treatment of complex diabetic foot ulcers.
Diabetic foot ulceration is a lesion, the result of alterations in sensitivity, known as peripheral neuropathy and peripheral arthropathy present in the arteries.
 
The more advanced the diabetes is, higher is the risk for the patient of suffering such an injury.

Factors that cause the development of diabetic foot:

  1.  Deformities of the foot or Charcot arthropathy
  2.  The poor control of diabetes
  3.  Neuropathy
  4.  Arteriopathy
  5.  Tobacco use

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. It 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 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 firt in its class. Its basic principles are based on research carried out by the American scientist Stanley Cohen in the 1960s after observing the behavior of many animal species of licking wounds, applying abundant saliva to the skin openings, a trait eberprot 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 humans also do, especially when they injure their fingers either by burns or cuts.

From 2001 to 2005, clinical trials II and III were initiated and concluded in different centers at 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.

Advantages of using Heberprot-P

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 quality of life of patients in Cuba. 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

Contraindications of Heberprot-P

1. This drug is contraindicated in patients with a history of hypersensitivity to the product or any of its components.
2. In patients sufferingr from decompensated heart disease, diabetic coma or diabetic ketoacidosis.
3. Patients suffering oncological pathologies, history or suspicion of any type of neoplasia.

Method of administration of Heberprot-P 75

Treatment with Hebrprot-P for diabetic foot ulcers consists of administering the drug at a rate of 75 ?g, diluted in 5 mL of water for injection, three times a week, perilesionally and intralesionally. The administration of HEBERPROT-P will be maintained until complete granulation of the lesion is achieved closing 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 patients enrolled in this program we observed a reduction of amputation rate of less than five percent.

PRODUCT COMPOSITION:
Each 5 mL bulb contains, depending on the dose:
 Note: FCEhrec is a peptide that stimulates cell proliferation and healing.
Componentes Cantidad mg/5 mL de agua
Recombinant human growth factor(FCEhrec) 0,075 µg ó 0.025 µg
Sucroise 15,000 mg
Dextran 40 5,000 mg
Sodium hydrogen phosphate 0,454 mg
Sodium dihydrogen phosphate dihydrate 1,061 mg
Water for injection 5 mL
Price and Treatment Program
HEBERPROT-P Cuban Medicine for the treatment of Diabetic Foot Ulcer
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