Status:
UNKNOWN
The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers
Lead Sponsor:
Mashhad University of Medical Sciences
Conditions:
Diabetic Foot Ulcers
Diabetic Wound
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 23 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04315909
Start Date
August 28 2019
End Date
June 23 2020
Last Update
March 20 2020
Active Locations (1)
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1
Alavi Hospital
Mashhad, Razavi Khorasan Province, Iran, 9137913316