RPCEC00000148RecruitingPhase 1
Pharmacokinetics of the Intralesional administration with two doses of rhEGF (75 µg and 225 µg) in patients with advance Diabetic Foot Ulcers
Center for Genetic Engineering and Biotechnology (CIGB)0 sites25 target enrollmentStarted: February 8, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment
Eligibility Criteria
- Ages
- 18 years to /A (No limit) (—)
- Sex
- All
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.
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