- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04315909
The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers
March 18, 2020 updated by: Daryoush Hamidi Alamdari, Mashhad University of Medical Sciences
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daryoush Hamidi Alamdari, Ph.D
- Phone Number: +98 51 3882 8574
- Email: hamidiad@mums.ac.ir
Study Contact Backup
- Name: Amir Yarahmadi, Ph.D
- Phone Number: +98 51 3882 8574
- Email: yarahmadiA961@mums.ac.ir
Study Locations
-
-
Razavi Khorasan
-
Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 9137913316
- Recruiting
- Alavi Hospital
-
Contact:
- Mohammad-Hadi Saeed Modaghegh, M.D
- Email: ModagheghMH@mums.ac.ir
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Platelet-Rich Plasma-Fibrin Glue
Other Names:
Vitamin E and vitamin C
|
Experimental: Control group
Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks.
|
Placebo
Platelet-Rich Plasma-Fibrin Glue
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing rate of the ulcer
Time Frame: 2 months
|
Examination by a vascular surgery physician and documentation
|
2 months
|
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.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum ESR at baseline and after the intervention
Time Frame: 2 months
|
Erythrocyte Sedimentation Rate
|
2 months
|
Serum hs-CRP at baseline and after the intervention
Time Frame: 2 months
|
high-sensitivity C-Reactive Protein
|
2 months
|
FBS at baseline and after the intervention
Time Frame: 2 months
|
Fasting blood sugar
|
2 months
|
HbA1c at baseline and after the intervention
Time Frame: 2 months
|
Glycated hemoglobin
|
2 months
|
Lipid Profile at baseline and after the intervention
Time Frame: 2 months
|
Serum Triglyceride, Cholesterol, HDL, LDL, VLDL
|
2 months
|
Serum Urea at baseline and after the intervention
Time Frame: 2 months
|
In a quantitative laboratory method
|
2 months
|
Serum Creatinine at baseline and after the intervention
Time Frame: 2 months
|
In a quantitative laboratory method
|
2 months
|
Serum total bilirubin at baseline and after the intervention
Time Frame: 2 months
|
In a quantitative laboratory method
|
2 months
|
Serum Uric acid at baseline and after the intervention
Time Frame: 2 months
|
In a quantitative laboratory method
|
2 months
|
Serum Homocysteine at baseline and after the intervention
Time Frame: 2 months
|
In a quantitative laboratory method
|
2 months
|
Pro-Oxidant Antioxidant Balance at baseline and after the intervention
Time Frame: 2 months
|
The PAB assay is a test to determine the oxidants and antioxidants simultaneously in one single test.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daryoush Hamidi Alamdari, Ph.D, Mashhad University of Medical Sciences, Mashhad, Iran
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2019
Primary Completion (Anticipated)
June 23, 2020
Study Completion (Anticipated)
June 23, 2020
Study Registration Dates
First Submitted
March 17, 2020
First Submitted That Met QC Criteria
March 18, 2020
First Posted (Actual)
March 20, 2020
Study Record Updates
Last Update Posted (Actual)
March 20, 2020
Last Update Submitted That Met QC Criteria
March 18, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Diabetic Foot
- Foot Ulcer
- Ulcer
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Hemostatics
- Coagulants
- Antioxidants
- Fibrin Tissue Adhesive
- Vitamin E
Other Study ID Numbers
- IR.MUMS.REC.1398.125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
All data related to the project after unidentifiable of people will be shared.
IPD Sharing Time Frame
Access to data are allowed 6 months after the publication of results.
IPD Sharing Access Criteria
The investigator's data will be available for university staffs and academic institutions.
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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