Diabetic foot ulcer.
Conditions
Interventions
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 c
Epidermal Growth Factor
Placebos
Sponsors
Center for Genetic Engineering and Biothecnology (CIGB), Havana.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactPedro López-Saura
Center for Biological Research.
Outcome results
None listed