CITOPROT-III

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000060
• Date of registration: 26/02/2009
• Primary sponsor: Center for Genetic Engineering and Biothecnology (CIGB), Havana City.
• Public title: CITOPROT-III
• Scientific title: Intralesional administration of recombinant Epidermal Growth Factor in patients with diabetic foot and risk of major amputation.
• Date of first enrolment: 27/09/2006
• Target sample size: 147
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000060-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 Biological Research.

• Name: Pedro López-Saura
• Affiliation: Center for Biological Research.

Key inclusion & exclusion criteria

Inclusion criteria: 1.Diagnosis of diabetic foot ulcer, Wagner's grade 3 or 4. 2.Age = 18 years. 3.Patient’s signed informed consent.
Exclusion criteria: 1.Ulcer area < 1 cm2. 2.Haemoglobin <100 g/l. 3.Uncompensated chronic diseases (ischemic heart illness, diabetic coma or ketoacidosis, renal failure). 4.History or suspect of malignancies (physical examination, rectal tact, breast examination, abdominal ultrasound, thorax radiography and blood chemistry). 5.Use of drugs that can impair evaluation: immunosuppressors or corticosteroids. 6.Psychiatric or neurological diseases that could impair proper reasoning for consent. 7.Pregnancy or nursing.

Age minimum: 18 years
Age maximum: No limit
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic foot ulcer.

Intervention(s)

Treatment groups are: Group I: EGF 75 µg Group II: EGF 25 µg Group III; Placebo Each vial to be dissolved with 5 mL water for injection; administered as intralesional infiltrations 3 times per week up to 8 weeks. Treatment should be discontinued if useful granulation tissue covers the whole lesion extension or its area is less than 1 cm2. Infiltrations should be done after lesion cure, on the ulcer borders, with 26 mm needles and on the ulcer bottom, in case of deep lesions, with 24 mm needles. Cleaner zones of the ulcers should be infiltrated first and needles to be changed for each puncture site in order to prevent infection transmission. Afterwards, the lesion should be covered with a saline-moistened clean gauze.

Primary Outcome(s)

Primary outcome variable: Proportion of patients with >50% granulation response after 2 weeks of treatment. Useful productive material is that able to lead to complete lesion closure by second intention or to sustain and feed an autograft. It is characterized macroscopically by the presence of granular, reddish, diffuse, disperse, shining, and easily bleeding formations. Response is classified according to the percent of the lesion area covered by granulation tissue: 1.No response: 0 – 25% 2.Minimal response: 26 – 50% 3.Partial response: 51 – 75% 4.Complete response: > 75 % Partial or complete response at 2 weeks of treatment are considered therapeutic success. No response or minimal response are considered failures.

Secondary Outcome(s)

1.Proportion of patients that achieve complete granulation response at the end of treatment. 2.Time to complete granulation response. 3.Proportion of patients that reaches complete healing up to one year follow-up, defined as wound epithelization and complete closure, without secretion or need of bandage. 4.Need for major amputation. 5.Recurrence, defined as the appearance of a new ulcer on the same limb, both at the same previously affected site or at a new site.

Secondary ID(s)

IG/FCEI/PD/0503

Source(s) of Monetary Support

Heber Biotec S.A., Ministry of Public Health (MINSAP).