Diabetic Foot Ulcers, Diabetic Wound
Conditions
Keywords
Platelet-Rich Plasma-Fibrin Glue, DFU, Vitamin E, Vitamin C, non-healing Diabetic Foot Ulcers
Brief summary
The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin Glue as an effective treatment for wound healing.
Interventions
DRUGPRP-Fibrin Glue
Platelet-Rich Plasma-Fibrin Glue
DIETARY_SUPPLEMENTVitamin E and C
Vitamin E and vitamin C
OTHERPlacebo
Placebo
Sponsors
Mashhad University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. DFU is classified as Wagner 1 -2 on the Wagner classification system. 2. Persons with type 1 or type 2 diabetes with a non-healing ulcer of at least 4 weeks duration. 3. If more than one non-healing wound is present, the largest of the wounds that is classified as a Wagner 1- 2. 4. The index ulcer had to be clinically non-infected. 5. Ankle Brachial Index (ABI) greater than or equal to 0.7. 6. HemoglobinA1C (HbA1c) \< 12 7. Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces). 8. Wound area (length x width) measurement between 2 cm2 and 20 cm2. 9. Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents. 10. No smoking, alcohol or drug addiction. 11. Approved, informed, signed consent.
Exclusion criteria
1. Previous consumption of vitamin E and C supplements. 2. Index ulcer has exposed tendons, ligaments, muscle, or bone. 3. Confirmed presence of osteomyelitis, or if osteomyelitis is suspected. 4. Patients with renal deficiency, hepatic failure, has known immune insufficiency and cancer. 5. Subject is pregnant or plans to become pregnant during the duration of the trial. 6. Patient's blood vessels are non-compressible for ABI testing. 7. Patient is known to have a psychological, developmental, physical, emotional disorders. 8. Received systemic corticosteroids or immunosuppressive agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing rate of the ulcer | 2 months | Examination by a vascular surgery physician and documentation |
| Wound Size | 2 months | Wound size will be measured with ruler for length, width as well as with digital imaging. Wound size will be assessed in digital images taken of the wound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FBS at baseline and after the intervention | 2 months | Fasting blood sugar |
| HbA1c at baseline and after the intervention | 2 months | Glycated hemoglobin |
| Lipid Profile at baseline and after the intervention | 2 months | Serum Triglyceride, Cholesterol, HDL, LDL, VLDL |
| Serum Urea at baseline and after the intervention | 2 months | In a quantitative laboratory method |
| Serum ESR at baseline and after the intervention | 2 months | Erythrocyte Sedimentation Rate |
| Serum total bilirubin at baseline and after the intervention | 2 months | In a quantitative laboratory method |
| Serum Uric acid at baseline and after the intervention | 2 months | In a quantitative laboratory method |
| Serum Homocysteine at baseline and after the intervention | 2 months | In a quantitative laboratory method |
| Pro-Oxidant Antioxidant Balance at baseline and after the intervention | 2 months | The PAB assay is a test to determine the oxidants and antioxidants simultaneously in one single test. |
| Serum Creatinine at baseline and after the intervention | 2 months | In a quantitative laboratory method |
| Serum hs-CRP at baseline and after the intervention | 2 months | high-sensitivity C-Reactive Protein |
Countries
Iran
Contacts
Primary ContactDaryoush Hamidi Alamdari, Ph.D
Backup ContactAmir Yarahmadi, Ph.D
Outcome results
None listed