The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Parallel-group, Clinical Trial to Evaluate the Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcers, Diabetic Wound

Intervention / Treatment
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* Drug: PRP-Fibrin Glue
* Dietary Supplement: Vitamin E and C
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DFU is classified as Wagner 1 -2 on the Wagner classification system. Persons with type 1 or type 2 diabetes with a non-healing ulcer of at least 4 weeks duration. If more than one non-healing wound is present, the largest of the wounds that is classified as a Wagner 1- 2. The index ulcer had to be clinically non-infected. Ankle Brachial Index (ABI) greater than or equal to 0.7. HemoglobinA1C (HbA1c) < 12 Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces). Wound area (length x width) measurement between 2 cm2 and 20 cm2. Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents. No smoking, alcohol or drug addiction. Approved, informed, signed consent. Exclusion Criteria: Previous consumption of vitamin E and C supplements. Index ulcer has exposed tendons, ligaments, muscle, or bone. Confirmed presence of osteomyelitis, or if osteomyelitis is suspected. Patients with renal deficiency, hepatic failure, has known immune insufficiency and cancer. Subject is pregnant or plans to become pregnant during the duration of the trial. Patient's blood vessels are non-compressible for ABI testing. Patient is known to have a psychological, developmental, physical, emotional disorders. Received systemic corticosteroids or immunosuppressive agents.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Drug: PRP-Fibrin Glue<br>* Platelet-Rich Plasma-Fibrin Glue<br>* Other names: Platelet-Rich Plasma-Fibrin Glue;Dietary Supplement: Vitamin E and C<br>* Vitamin E and vitamin C<br>|
| Experimental: Control group<br>Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks. | Drug: PRP-Fibrin Glue<br>* Platelet-Rich Plasma-Fibrin Glue<br>* Other names: Platelet-Rich Plasma-Fibrin Glue;Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet-Rich Plasma-Fibrin Glue, DFU, Vitamin E, Vitamin C, non-healing Diabetic Foot Ulcers