Treatment of trophic ulcers in feet with diabetes diagnosis, Cuba.
HEBERPROT-P is a unique Cuban drug for treatment of trophic ulcers both ischemic and neuropathic. It also can be applied when treatment of trophic ulcer complications such as osteomyelitis and gangrene.
HEBERPROT-P has been developing in the capital Center of gene engineering and vascular surgery (Неberbiotec) for about 20 years.
Currently it is widely used in Cuban specialized medical units but it does not go on sale.
Mechanism of action of HEBERPROT-P
Active substance HEBERPROT-P is an epidermal growth factor (EGF), which acts directly at the wound area. Human recombinant epidermal growth factor (HEGFr) is a highly purified peptide consisting of 53 amino acids with a molecular weight of 6054 daltons and an isoelectric point of 4.6.
The substance activates the migration and proliferative properties of fibroblasts, keratinocytes and other cells that contribute to ulcer healing, normal epithelial growth and tissue renewal.
The drug regulates the body’s processes of metabolism and recovery. Getting combined with receptors on the surfaces of cell membranes, HEBERPROT-P activates anti-inflammatory processes, as well as differentiation of regenerating cells, due to which the wound heals quickly enough and qualitatively.
In addition, the substance controls the growth of epithelial, endothelial cells and fibroblasts, accelerates proliferative processes in tissues, and stabilizes the motor response of cells as a result of stimuli action.
Composition and production form of HEBERPROT-P
White lyophilizate for injection solution. 1 vial contains 0.075 mg of Human recombinant epidermal growth factor. Excipients: sucrose 15 mg, dextran 40 5 mg, sodium dihydrogen phosphate dihydrate 1.061 mg, sodium hydrogen phosphate 0.454 mg. The prepared solution makes a clear, colorless, homogeneous liquid without suspended particles.
Method of application of HEBERPROT-P
HEBERPROT-P is applied at the rate of one vial per a patient. The wound surface is cleaned with a sterile physiological solution and dry sterile gauze wipes. The affected area should be measured in cm2. Ten injections per 0,5 ml should be done for treating ulcers with the area of more than 10 cm2. Injections are done in soft tissues, first of all, by needling the wound edges, and then the wound bed of the wound. The depth of needle insertion during injection should be about 0.5 cm.
Advantages of HEBERPROT-P when treatment of diabetic feet
- accelerates healing of strong lesions with a syndrome of ischemic and neuropathic diabetic feet; 3 weeks were enough for granulation of affected spots with dimensions of 1 up to 80 cm2
- reduces a number of sanitations and surgical interferences;
- reduces risk of infections and superinfections of lower limb ulcers of patients with gangrene, what reduces a number of surgeries a lot;
- greatly improves patients’ quality life with trophic ulcers due to the fact of decrease of surgical interferences and prevents from recurrences;
- cut expenses on hospitalizing as a cost of treatment with HEBERPROT-P is much more lower than that of endovascular surgeries and there are no complications typical for surgery.
Competent treatment with the current drug is able to prevent from lower limb amputation. According to the tests made effect from the treatment starts in 2 weeks after beginning of the treatment (injection course).
Results of treatment with HEBERPROT-P
In accordance with clinic tests ulcers of 50% of patients, who have completed a treatment course with this drug, were completely treated and 70% of patients managed to avoid amputations.