Diabetic foot ulcer. Diabetes mellitus due to underlying condition
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Type 2 diabetes and a chronic (at least 6 weeks) full-thickness (above or below the malleolus) foot ulcer with a cross-sectional area of ??more than 25 mm2. Diabetic foot ulcer in one area of ??the foot and in one leg and below the ankle Hospital admission for wound management within 48 hours of starting standard treatment.
Exclusion criteria
Exclusion criteria: Patients who have started standard treatment for diabetic foot ulcers and 48 hours have passed. Patients with wounds other than diabetic foot ulcers, such as surgical wounds. Patients with immunodeficiency, or patients taking immunosuppressive drugs. Patients with diabetic ulcers with Wagner grade 0, 1, 4 and 5 and may be in the inpatient ward for any reason. Patients who are candidates for surgery. Patients who, after discharge from the hospital, continue their treatment at home or in other centers not associated with this plan. Patients who take alteplase, heparin, tricyclic antidepressants and other anticholinergic drugs. In such patients, if the doctor determines that the prescription of TNG is not contraindicated, it will be taken on a case-by-case basis. People who have consumed alcohol in the past 24 hours. Lactating mothers Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer surface area. Timepoint: Before the study, then at weekly intervals until the end of the study. Method of measurement: Taking a picture of the wound at a certain distance and one meter away and then analyzing it with image analysis software such as ImageJ.;Wound healing duration. Timepoint: From the time of starting treatment until the wound closes, if not more than three months. Method of measurement: Time interval based on days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay due to wound. Timepoint: The interval between admission and discharge if the discharge is due to recovery and not other reasons, such as changing treatment centers. Method of measurement: Time interval based on days.;Biochemical and hematological parameters as baseline variables such as CBC, Na, K, HbA1c, fasting glucose and insulin. Timepoint: Before and after the intervention. Method of measurement: The concentration of the parameter in the blood: glucose, mg/dL; insulin, mmol/L; sodium and potassium, milliequivalents/L; CBC, cells by number per ml of blood and their percentage relative to each other. | — |
Countries
Iran (Islamic Republic of)
Contacts
Dezfoul University of Medical Sciences