Diabetic Foot Ulcer. Other specified diabetes mellitus
Conditions
Interventions
Intervention 1: Recipients of the plant-based polyurethane-silicone polymer foam wound dressing will receive the allocated intervention for 4 weeks. Polymeric foam will be produced by Kimia Kosar Azar
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
Inclusion criteria: Voluntary participation in research involves adhering to the protocol requirements, accepting the related implementation stages, and signing the informed consent form Age over 18 years and less than or equal to 75 years Suffering from Type I or Type II diabetes Diabetic foot ulcer size between 1 cm2 to 12 cm2 Wound grading of I, II, or III according to the Wagner scale, extending to the skin, tendon, and subcutaneous tissue without evidence of active wound infection at the time of eligibility for study participation Free of necrotic remnants in the target wound Blood glycosylated hemoglobin level (HbA1c) less than or equal to 10% Satisfactory blood circulation to the wound is confirmed by measuring systolic blood pressure in the posterior tibial or anterior tibial artery (more than 50 mmHg) of the affected limb 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 (IV) 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 Individuals with a clinical history of alcohol or drug abuse. History of surgery for malignant tumors within the past five years, excluding carcinoma in situ. Individuals currently enrolled in another clinical study. Individuals who have received treatment for wounds with growth factors, skin substitutes, or other biological therapies in the past 30 days. Individuals receiving systemic corticosteroids (oral or injectable), immune-suppressing medications, or cytotoxic drugs with unstable doses prior to 4 weeks ago.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the size of diabetic foot ulcer. Timepoint: The beginning study, forth week. Method of measurement: Using a transparent foil over the wound and drawing the edges of the wound with a permanent marker, scan and analyze with ImageJ software.;Time required for 50% reduction in initial wound size. Timepoint: The beginning study, forth week. 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: At the beginning, at forth week. Method of measurement: Using the simplified Bates-Jensen wound assessment questionnaire, parts 7-13.;Changes in wound pain score. Timepoint: At the beginning, at forth week. Method of measurement: Using a visual analog scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzizeh Farshbaf-Khalili
Tabriz University of Medical Sciences
Outcome results
None listed