Diabetic foot ulcers.
Conditions
Interventions
Heberprot-P be administered intralesional in a single dose level (75 ug), on alternate days to a maximum of 8 weeks or until ulcer closure if it occurs earlier.
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB).
Ministry of Public Health, CUBA.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Have given informed consent. 2) Patients with diabetes mellitus type 1 or 2 according to the criteria of the American Diabetes Association. 3) Age = 18 years. 4) Diabetic foot ulcer deep, complicated, and no clinical signs of infection. 5) Diabetic foot ulcer with an area = 2 cm2. 6) Patients with ischemic ulcers with pressures between 0.8 to 0.3 index.
Exclusion criteria
Exclusion criteria: 1) Signs or symptoms of local infection. 2) Complete granulating ulcer. 3) Pretreatment with epidermal growth factor (EGF) topically or by any means in order to study injury or other injury in the 4 weeks prior to treatment with EGF. 4) Connective tissue diseases. 5) Decompensated or severe systemic diseases: heart disease (acute myocardial infarction in the previous three months, unstable angina or heart failure with edema), moderate or severe hepatic insufficiency, renal insufficiency with serum creatinine > 200 umol/L. 6) Current or history of malignancy in the past. 7) Psychiatric or neurological diseases that prevent the patient to give consent to participate in the study. 8) Hemoglobin < 100 g/L. 9) Clinical signs of malnutrition or albumin < 30 g/L. 10) Hypersensitivity to the product or any of its components. 11) Pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Differential gene expression, at the beginning and the 3rd week of treatment. - Percent of granulation of the injury, at first, 3rd and 8th week post-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to reach 75% or more of granulation (days, months). Measuring time: in weeks 3, 8, 12, 16 and 20 post-treatment. - Total closure of the injury (Yes, No). Measuring time: at weeks 12, 16 and 20 post-treatment. - Adverse events (Event number; Type; Frequency: Yes, No; Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events; Duration: hours, days, months; Causal relationship: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death; Treatment indicated: type and dosage of medication, treatment time). Measuring time: in weeks 3, 8, 12, 16 and 20 post-treatment. | — |
Countries
Cuba
Contacts
Public ContactDr. Julio Baldomero Hernández
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed