RPCEC00000117RecruitingPhase 4

Evaluation of molecular response to treatment with Heberprot-P in patients with diabetic foot ulcers”.

Center for Genetic Engineering and Biotechnology (CIGB).0 sites156 target enrollmentStarted: May 20, 2011Last updated: August 19, 2024

Conditions

Trial Snapshot

No summary available.

Study Type: Interventional
Allocation: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•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.

•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.

Sponsor

Center for Genetic Engineering and Biotechnology (CIGB).