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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus vitamin supplements (E (200 IU/ 2day) and C (250 mg/ 2day) ) for 8 weeks. |
|
| Control group | Experimental | Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP-Fibrin Glue | Drug | Platelet-Rich Plasma-Fibrin Glue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing rate of the ulcer | Examination by a vascular surgery physician and documentation | 2 months |
| Wound Size | 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ESR at baseline and after the intervention | Erythrocyte Sedimentation Rate | 2 months |
| Serum hs-CRP at baseline and after the intervention | high-sensitivity C-Reactive Protein |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daryoush Hamidi Alamdari, Ph.D | Contact | +98 51 3882 8574 | hamidiad@mums.ac.ir | |
| Amir Yarahmadi, Ph.D | Contact | +98 51 3882 8574 | yarahmadiA961@mums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Daryoush Hamidi Alamdari, Ph.D | Mashhad University of Medical Sciences, Mashhad, Iran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alavi Hospital | Recruiting | Mashhad | Razavi Khorasan Province | 9137913316 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33646060 | Derived | Yarahmadi A, Saeed Modaghegh MH, Mostafavi-Pour Z, Azarpira N, Mousavian A, Bonakdaran S, Jarahi L, Samadi A, Peimani M, Hamidi Alamdari D. The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: a randomized, double-blind, parallel-group, clinical trial. Expert Opin Biol Ther. 2021 May;21(5):687-696. doi: 10.1080/14712598.2021.1897100. Epub 2021 Apr 13. |
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All data related to the project after unidentifiable of people will be shared.
Access to data are allowed 6 months after the publication of results.
The investigator's data will be available for university staffs and academic institutions.
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| Vitamin E and C | Dietary Supplement | Vitamin E and vitamin C |
|
| Placebo | Other | Placebo |
|
| 2 months |
| FBS at baseline and after the intervention | Fasting blood sugar | 2 months |
| HbA1c at baseline and after the intervention | Glycated hemoglobin | 2 months |
| Lipid Profile at baseline and after the intervention | Serum Triglyceride, Cholesterol, HDL, LDL, VLDL | 2 months |
| Serum Urea at baseline and after the intervention | In a quantitative laboratory method | 2 months |
| Serum Creatinine at baseline and after the intervention | In a quantitative laboratory method | 2 months |
| Serum total bilirubin at baseline and after the intervention | In a quantitative laboratory method | 2 months |
| Serum Uric acid at baseline and after the intervention | In a quantitative laboratory method | 2 months |
| Serum Homocysteine at baseline and after the intervention | In a quantitative laboratory method | 2 months |
| Pro-Oxidant Antioxidant Balance at baseline and after the intervention | The PAB assay is a test to determine the oxidants and antioxidants simultaneously in one single test. | 2 months |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| ID | Term |
|---|---|
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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