Diabetic Foot Ulcer. Type 1& 2 diabetes mellitus with foot ulcer
Conditions
Interventions
Intervention group: 250 microliters of intralesional epidermal growth factor preparation at a concentration of 25 micrograms per microliter.
Sponsors
Borna Biopharma company
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: signing the informed consent Age>18 Confirmed diagnosis of type I or type II HbA1c=12% Diabetic Foot bearing the following criteria: A - The size of the ischemic or neuropathic wound is between 0.5 and 12 cm2. B - The Wegener grade 2 to 4. D - The wound has been unhealed for at least 4 weeks. E - In case of multiple wounds, the largest wound that meets the criteria is selected and the distance from other wounds should be at least 2 cm. F - In case of amputation wound, if the other criteria are met, it can be used for this study. G - There is adequate perfusion (good and strong leg pulses) in the wound area. If the leg pulse is weak, assessment of perfusion pressures is performed with Doppler ultrasound.
Exclusion criteria
Exclusion criteria: The patient has a known history of alcohol or drug abuse Use of any antibiotic medication in the past 7 days prior to first use of the study product The presence of a diabetic foot ulcer with Wagner grade 1 in the patient Presence of serious comorbidities such as cancer, NYHA class IV heart failure, severe anemia (Hb 39 Received previous treatment similar to the gel studied in this clinical protocol Participation in another clinical trial within 30 days prior to the study entry visit Taking or receiving a medication or treatment that, in the researcher's opinion, has a proven effect on the speed and quality of wound healing or affects different stages of the healing process. The likelihood of needing to receive systemic corticosteroids during the study Immobility of the patient Pregnancy and breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound characteristics include wound size, depth, and severity based on Wegener's criteria, presence of granulation tissue, edema, erythema, and infection. Timepoint: Every 48 hours. Method of measurement: Clinical examination and measurement of wound size and depth in centimeters and wound severity according to Wegener's criteria. Examination of wound infection will be performed by examination and, if necessary, tissue culture. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Shivering and sweating, 2. nausea and vomiting, 3. pain at the injection site, 4. hypotension, 5. burning sensation, 6. fever, 7. hypertension, 8. erythema, 9. chest pain, 10. palpitations, 11. syncope, 12. shortness of breath, 13. confusion, and 14. necrosis. Timepoint: Every 48 hours. Method of measurement: The patient is asked about their symptoms and recorded in a questionnaire. The symptoms are assessed by clinical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKeivan Majidzadeh Ardebili
Iranian academic center for education culture and research
Outcome results
None listed