Diabetic Foot Ulcer. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group 1: people with diabetic foot ulcers who receive secretum for the treatment of diabetic foot ulcers. Intervention 2: Intervention group 2: People with diabetic foot u
Sponsors
Qazvin University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: Voluntary participation in the research by complying with the requirements of the protocol and accepting the steps related to its implementation and signing the informed consent form Age over 30 years and less than 60 years Suffering from type I or type II diabetes Diabetic foot ulcer size between 1 cm2 to 12 cm2 Type II or type III wound with Wagner grading and spread to skin, tendon and subcutaneous tissue without evidence of active wound infection at the time of eligibility to participate in the study Free of necrotic remnants in the target wound Blood glycosylated hemoglobin level (HbA1c) 50 mmHg) of the affected limb General health status, which according to the researcher, allows the patient to participate in all stages of the study
Exclusion criteria
Exclusion criteria: 1. Non-diabetic pathophysiological wound. 2. People who need intravenous (IV) antibiotics to treat infection. 3. Current evidence of infection, including drainage of pus from the wound site. 4. People with severe kidney failure who cannot be managed with kidney dialysis. 5. People with severe liver failure. 6. Human immunodeficiency virus (HIV) positive 7. People who have an allergic reaction or hypersensitivity to natural proteins and polysaccharides. 8. Pregnancy or breastfeeding 9. People with a clinical history related to alcohol or drug abuse. 10. Suffering from a disease that can affect the study. 11. People who have had a history of malignant tumor surgery in the last five years (with the exception of carcinoma in situ). 12. People who are currently enrolled or in another clinical study. 13. People who have undergone wound treatment with growth factors, skin substitutes or other biological treatments in the last 30 days. 14. People who receive oral or injectable corticosteroids, immunosuppressant or cytotoxic drugs with unstable dosage before 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound closure rate. Timepoint: Wound healing rate after 1, 7, 14, 28, 60. Method of measurement: Wound size is evaluated using a 3D digital wound imaging device with image processing software. | — |
Secondary
| Measure | Time frame |
|---|---|
| Amputation rate. Timepoint: The amount of amputation after 1, 7, 14, 28 days. Method of measurement: Tissue size.;Skin edema. Timepoint: The amount of skin edema after 1, 7, 14, 28 days. Method of measurement: Reduction of swelling and accumulation of fluids with the weight grading system for skin size results in +1 to +4. It is evaluated by applying pressure on the damaged area and then measuring the depth of the pit (with a ruler) and its duration (return time). Degree of +1 to 2 mm indentation, setting the return time using a timer.;Infection. Timepoint: The rate of infection after 1, 7, 14, 28 days. Method of measurement: Bacterial culture. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossein Piri
Qazvin University of Medical Sciences
Outcome results
None listed