Pharmacokinetics of the Intralesional administration of rhEGF (doses: 75 µg and 225 µg) in advance Diabetic Foot Ulcers

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000148
• Date of registration: 08/02/2013
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB)
• Public title: Pharmacokinetics of the Intralesional administration of rhEGF (doses: 75 µg and 225 µg) in advance Diabetic Foot Ulcers
• Scientific title: Pharmacokinetics of the Intralesional administration with two doses of rhEGF (75 µg and 225 µg) in patients with advance Diabetic Foot Ulcers
• Date of first enrolment: 27/07/2012
• Target sample size: 25
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000148-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Verena Amaurys Pedro Julio Muzio-González, PhD del Río-Martín, MD López-Saura, PhD Baldomero-Hernández, MD
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB)

• Name: Verena Amaurys Pedro Julio Muzio-González, PhD del Río-Martín, MD López-Saura, PhD Baldomero-Hernández, MD
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Written, informed consent to participate, previous to any procedure described in the protocol. 2. Age = 18 years. 3. Size of the ulcer = 10 cm2 and = 30 cm2. 4. Deep and ischemic ulcers, to reach subcutaneous cellular tissue up to tendon or joint capsule, bone, with or not bone exposition, without osteomyelitis and infection. 5. Pressure index Ankle/Brachial = 0,6 < 0,9. 6. Ulcers = 4 weeks of evolution (treated or not). 7. Women into fertile age should use an effective contraceptive method until three months after the treatment has concluded.
Exclusion criteria: 1. Hemoglobin <100 g/L. 2. Connective tissue diseases. 3. Morbid obesity (body mass index > 40). 4. Use of drugs that could interfere (corticosteroids or immunosuppressants) or favor the healing (prostaglandin and others growth factors). 5. Systemic decompensated or severe diseases (Ischemic heart disease or diabetic coma), moderaty or severe liver failure (ALT, AST or GGT twices over the normal value and prothrombin values 3 sec. over the control), or renal failure with creatinine values > 200 µmol/L. 6. Signs of clinical malnutrition or albumin levels < 30 g/L. 7. Hypersensibility to any of to the components of the product. 8. Antecedents or suspicion of malignant diseases by general physical examination, thorax radiography, abdominal and pelvic ultrasound, ginecological examination, rectal tact, PSA. 9. Impossibility to complete with the foresee evaluations and visits. 10. Treatment with any EGF formulation within the 3 previous months. 11. Psychiatric or neurological diseases that impede the patient to give their consent. 12. Alcoholism story in the last two months (consumption not less than 1/4 bottle of rum or 1 bottle of wine or 3 beers, at a frequency not less than 3 times a week) or addiction to drugs in the previous year. 13. Pregnancy or nursing.

Age minimum: 18 years
Age maximum: N/A (No limit)
Gender: Both

Health Condition(s) or Problem(s) studied

Deep Ischemic Diabetic Foot Ulcers that reach joint capsule and bone, with or not bone exposition, without osteomyelitis and infection.

Intervention(s)

All the patients will receive the same treatment. The application will start with 75 µg three time per week during the first week, follow up to 225 µg once per week up to 8 week or less if patients closure of lesion before.

Primary Outcome(s)

EGF plasmatic levels (ELISA tecnhique). Measuring times: at the screening, 0 h (before first injection) and 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 12 h and 24 h after each application of 75 or 225 µg. Severe adverse events (Appearance of severe adverse events (Yes, No). Measuring time: at each administration during the 8 weeks of treatment.

Secondary Outcome(s)

Complete closure of the lesion (defined by the epithelization and total closure of the lesion without secretion or dressing application). Measuring time: before treatment, and weeks 4, 8, 12, 16 and 20. One-hundred percent of soft granulation tissue. Measuring time: before treatment, and weeks 4, 8, 12, 16 and 20. Clinical adverse events (AE). Measuring time: at each administration during 8 weeks of treatment -Appearance of AE (Yes, No) -Type of AE (name of the AE) -Duration (time between beginning and end of the event), -Intensity of AE (mild, moderate, severe) -Relation of causality (remote, possible, probable, very probable) -Result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation). Anti-EGF antibodies (by ELISA technique. Patients that develop antibodies (Yes, No)). Measuring time: before treatment, week 8 and week 20.

Secondary ID(s)

IG/FCEI/PD/1114

Source(s) of Monetary Support

Center for Genetic Engineering and Biotechnology (CIGB)

Secondary Sponsor(s)

Not applicable