Clinical trial, phase II, to evaluate rhEGF efficacy and safety at a dose of 25 or 75 micrograms intralesionally in patients with diabetic foot ulcer (Wagner grade 1 or 2).

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000048
• Date of registration: 24/12/2010
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana.
• Public title: Clinical trial, phase II, to evaluate rhEGF efficacy and safety at a dose of 25 or 75 micrograms intralesionally in patients with diabetic foot ulcer (Wagner grade 1 or 2).
• Scientific title: Phase II, multi-centered, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety of recombinant human Epidermal Growth Factor (rhEGF) at a dose of 25 or 75 micrograms intralesionally 3 times a week for up to 12 weeks, in patients with diabetic foot ulcer (Wagner grade 1 or 2).
• Date of first enrolment: 02/07/2009
• Target sample size: 35
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000048-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Pedro López Saura
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Dr. Amaurys del Río Martín
• Affiliation: Center for Genetic Engineering and Biotechnology. (CIGB)

Key inclusion & exclusion criteria

Inclusion criteria: 1) Patients with DM type 1 or 2 under ADA criteria. 2) Patients of both sexes, aged >= 18. 3) Diabetic foot ulcers classified by Wagner as grade 1 covering an area >10 and =50 cm2 or grade 2 covering an 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 not exceed 0.7. 5) Ulcer = 4 week evolution. 6) Reproductive age men and women should use effective contraceptive methods for up to three months after completing treatment. 7) Patients should give their consent.
Exclusion criteria: 1. Infection signs or symptoms. 2. Osteomyelitis or ulcers with bone exposure. 3. Poorly controlled diabetes mellitus (Hb A1c > 10%). 4. Connective tissue diseases. 5. Use of drugs likely to interfere with (corticoids or inmunosuppressors) or to favor cicatrisation (pentoxifylline, prostaglandin and other growth factors) in the previous 3 weeks. 6. Uncontrolled systemic or serious diseases: cardiopathies (acute myocardial infarction < 3 months, unstable angina or heart failure with edema), moderate or serious liver failure, kidney failure with serum creatinine values > 200mmol/L. 7. Clinical malnutrition signs or albumin levels < 30 g/L. 8. 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 intralesional EGF treatment in current lesion or < 4 weeks in any other lesion, or topical EGF < 4 weeks in current lesion. 13. Psychiatric or neurological diseases preventing informed consent. 14. History of alcoholism or drug addiction one year prior to inclusion. 15. Pregnancy or breastfeeding.

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

Health Condition(s) or Problem(s) studied

Patients with diabetic foot ulcer (Wagner grade 1 or 2).

Intervention(s)

One vial (75 ug, 25 ug or placebo, as appropriate) will be administered intralesionally 3 times a week until lesion occlusion or for up to 12 weeks. Vial reconstitution and dilution will be performed using 5 mL of injection water. The product will be spread over the lesion applying 0.5 - 1 mL during each infiltration. When lesion size gets smaller than 1 cm2, the number of injections and the volume to be administered will be determined by researcher, depending on lesion size and resistance.

Primary Outcome(s)

Total lesion occlusion 12 weeks after commencing treatment. The lesion will be considered occluded when epithelization occurs and there is no secretion and need for dressing. This event will show therapeutic success or failure, respectively.

Secondary Outcome(s)

Total lesion occlusion at 4th, 8th, 16th, and 20th weeks. Time required for total lesion occlusion. Occlusion in 50% of the initial ulcer area. The number of patients exhibiting 50% of ulcer occlusion at 4th, 8th, 12th, 16th, and 20th weeks will be determined. Time required for 50% lesion occlusion. Development of granular tissue in 90% of lesion area. The number of patients exhibiting this effect at 4th and 8th weeks will be determined. When lesion area is reduced, the granulated and occluded areas are added up, and the percentage based on the area measured before applying the product is calculated. Time required for granular tissue formation in 90% of ulcer area. Systemic EGF concentration after intralesional application.

Secondary ID(s)

IG/FCEI/PD/0708

Source(s) of Monetary Support

Center for Genetic Engineering and Biotechnology (CIGB) Praxis Pharmaceutical.

Secondary Sponsor(s)

Praxis Pharmaceutical.