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
Overview
- Phase
- Phase 2
- Intervention
- PRP-Fibrin Glue
- Conditions
- Diabetic Foot Ulcers
- Sponsor
- Mashhad University of Medical Sciences
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Healing rate of the ulcer
- Last Updated
- 6 years ago
Overview
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.
Investigators
Daryoush Hamidi Alamdari
Associate professor
Mashhad University of Medical Sciences
Eligibility Criteria
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-
- •The index ulcer had to be clinically non-infected.
- •Ankle Brachial Index (ABI) greater than or equal to 0.
- •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 cm
- •Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents.
- •No smoking, alcohol or drug addiction.
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.
Arms & Interventions
Intervention group
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.
Intervention: PRP-Fibrin Glue
Intervention group
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.
Intervention: Vitamin E and C
Control group
Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks.
Intervention: PRP-Fibrin Glue
Control group
Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Healing rate of the ulcer
Time Frame: 2 months
Examination by a vascular surgery physician and documentation
Wound Size
Time Frame: 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 Outcomes
- Serum ESR at baseline and after the intervention(2 months)
- Serum hs-CRP at baseline and after the intervention(2 months)
- HbA1c at baseline and after the intervention(2 months)
- Serum Urea at baseline and after the intervention(2 months)
- Serum total bilirubin at baseline and after the intervention(2 months)
- Serum Uric acid at baseline and after the intervention(2 months)
- FBS at baseline and after the intervention(2 months)
- Lipid Profile at baseline and after the intervention(2 months)
- Serum Creatinine at baseline and after the intervention(2 months)
- Serum Homocysteine at baseline and after the intervention(2 months)
- Pro-Oxidant Antioxidant Balance at baseline and after the intervention(2 months)