healing wound. Type 1 diabetes mellitus with circulatory complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Middle-aged men and women (40 to 64 years old) • Suffering from a diabetic foot ulcer for at least 4 weeks, or suffering from an amputation wound The initial area of the wound should be measured at least 0.5 and at most 25 square centimeters in the first visit Having a wound with Wegener grade 1 and 2 (Wegener grade is explained below) • Sufficient blood supply to the involved organ during the three months before the start of the study, which is determined by the ankle brachial index of 0.7 to 1.3 The studied wound has no necrotic tissue and needs debridement for at least 14 days before
Exclusion criteria
Exclusion criteria: Suffering from an uncontrolled major disease such as serious cardiovascular disease, kidney, liver, lung, lupus, anemia, tuberculosis and patients undergoing palliative treatment. Patients with an active malignancy, or a history of malignancy in the wound Sensitivity to treatment components Patients with a history of taking immunosuppressive drugs for more than 2 weeks, such as corticosteroids more than 10 mg daily and cytotoxic chemotherapy drugs, or placing topical steroids on the wound for at least one month before entering the study, or during the study. or predicting the need for such treatment in the course of the study HbA1C >12%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete healing of diabetic wounds. Timepoint: every 48 hours for 12 weeks. Method of measurement: Patients' wounds are photographed during each follow-up stage, and these images undergo two-dimensional and three-dimensional assessment using the newest Tissue Analytics software for Android.;Percentage reduction of diabetic ulcers. Timepoint: every 48 hours for 12 weeks. Method of measurement: Patients' wounds are photographed during each follow-up stage, and these images undergo two-dimensional and three-dimensional assessment using the newest Tissue Analytics software for Android.;Incidence of dressing Complications. Timepoint: every 48 hours for 12 weeks. Method of measurement: Patients' wounds are photographed during each follow-up stage, and these images undergo two-dimensional and three-dimensional assessment using the newest Tissue Analytics software for Android. | — |
Countries
Iran (Islamic Republic of)
Contacts
Babol University of Medical Sciences