Diabetic Foot Ulcer. Other specified diabetes mellitus
Conditions
Interventions
Intervention 1: The first intervention group: recipients of secretome spray along with routine dressing, who will receive the allocated intervention for 8 weeks. The dressing will be changed once a we
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
Inclusion criteria: Type I, II, or III diabetes with Wagner classification without evidence of active wound infection Diabetic foot ulcer size between 1 cm2 to 12 cm2 Free of necrotic remnants in the target wound Blood glycosylated hemoglobin level (HbA1c) <=10% Satisfactory blood circulation to the wound The possibility of patient participation in all stages of the study based on the general health status
Exclusion criteria
Exclusion criteria: Non-diabetic pathophysiological ulcer People who need intravenous antibiotics to treat infection Current evidence of infection, including drainage of pus from the wound site. People with severe kidney failure who cannot be managed with kidney dialysis People with severe liver failure Human immunodeficiency virus (HIV) positive Excessive allergic reaction to natural proteins and polysaccharides Pregnancy or breastfeeding No history of malignant tumor surgery in the last 5 years (except carcinoma in situ). Receiving immunosuppressive treatments in the last 30 days Receiving growth factors, skin substitutes, or other biological therapies to treat the ulcer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of enrollment and retention of participants in study groups. Timepoint: During two months of intervention. Method of measurement: Researcher's own follow-up.;Changes in the size of diabetic foot ulcer. Timepoint: The beginning and end of the intervention. Method of measurement: By marking the edge of the wound on the transparent screen, scanning and analysis with special software.;Time required for 50% reduction in initial wound size. Timepoint: During the intervention with weekly visits. Method of measurement: By marking the edge of the wound on the transparent screen, scanning and analysis with special software. | — |
Secondary
| Measure | Time frame |
|---|---|
| The score of wound morphology indicators (amount of secretions, characteristics of wound secretions, presence of redness and/or edema in the wound around the skin, presence of granular tissue, or epithelization). Timepoint: The beginning and end of the intervention. Method of measurement: Using the simplified Bates-Jensen wound assessment questionnaire, parts 7-13.;Changes in wound pain score. Timepoint: The beginning and end of the intervention. Method of measurement: Using a visual analog scale.;Changes in the quality of life score. Timepoint: The beginning and end of the intervention. Method of measurement: Using a diabetic foot ulcer scale–Short Form: DFS-SF.;The rate and severity of adverse events in the study groups. Timepoint: During intervention. Method of measurement: Through recording in the questionnaire and phone calls. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzizeh Farshbaf-Khalili
Tabriz University of Medical Sciences
Outcome results
None listed