RPCEC00000047
Completed
Phase 1
Pharmacokinetics in intralesional administration of recombinant Epidermal Growth Factor in patients with diabetic foot ulcers.
Center for Genetic Engineering and Biotechnology (CIGB), Havana.0 sites16 target enrollmentDecember 24, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetic foot ulcer, Wagner grades 1 or 2
- Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB), Havana.
- Enrollment
- 16
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with DM type 1 or 2 under ADA criteria. 2\. Patients of both sexes, aged \>\= 18 and \<\= 70\. 3\. Diabetic foot ulcers classified by Wagner as grade 1 (covering an area \>10 and \=50 cm2\) or grade 2 (covering and area \>1 and \=50 cm2\). 4\. Neuropathic ulcer evidenced by palpable distal pulses and ankle/arm index (AA/I) \= 0\.8 and \< 1\.3\. If arterial calcification occurs (AA/I \= 1\.3\), the finger/arm index (FA/I) will be used. It should be over 0\.7\. 5\. Ulcer \= 4 week evolution. 6\. Reproductive age men and women should use effective contraceptive methods up to three months after completing treatment. 7\. Patients giving informed consent.
Exclusion Criteria
- •1\. Infection signs or symptoms. 2\. Osteomyelitis or ulcers with bone exposure. 3\. Poorly controlled diabetes mellitus (Hb A1c \> 10%). 4\. Morbid obesity (body mass index \> 40\). 5\. Connective tissue disease. 6\. Use of drugs likely to interfere with (corticoids or inmunosuppressors) or to favor cicatrisation (pentoxifylline, prostaglandin, and other growth factors). 7\. Uncontrolled systemic or serious diseases: cardiopathies (especially ischemic cardiopathy or heart failure with edema), moderate or serious liver failure, kidney failure with serum creatinine values \>200mmol/l. 8\. Clinical malnutrition signs or albumin levels \< 35 g/L. Hemoglobin \< 100g/L. 9\. Hypersensitivity to the product or any of its components. 10\. History of current or past neoplasia. 11\. Failure to conduct relevant evaluations or keep appropriate drainage in affected limb. 12\. Previous EGF treatment. 13\. Psychiatric or neurological diseases preventing informed consent. 14\. History of alcoholism or drug addiction one year prior to inclusion. 15\. Pregnancy or breastfeeding.
Outcomes
Primary Outcomes
Not specified
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