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

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

Study Locations

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:

  1. DFU is classified as Wagner 1 -2 on the Wagner classification system.
  2. Persons with type 1 or type 2 diabetes with a non-healing ulcer of at least 4 weeks duration.
  3. If more than one non-healing wound is present, the largest of the wounds that is classified as a Wagner 1- 2.
  4. The index ulcer had to be clinically non-infected.
  5. Ankle Brachial Index (ABI) greater than or equal to 0.7.
  6. HemoglobinA1C (HbA1c) < 12
  7. Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces).
  8. Wound area (length x width) measurement between 2 cm2 and 20 cm2.
  9. Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents.
  10. No smoking, alcohol or drug addiction.
  11. Approved, informed, signed consent.

Exclusion Criteria:

  1. Previous consumption of vitamin E and C supplements.
  2. Index ulcer has exposed tendons, ligaments, muscle, or bone.
  3. Confirmed presence of osteomyelitis, or if osteomyelitis is suspected.
  4. Patients with renal deficiency, hepatic failure, has known immune insufficiency and cancer.
  5. Subject is pregnant or plans to become pregnant during the duration of the trial.
  6. Patient's blood vessels are non-compressible for ABI testing.
  7. Patient is known to have a psychological, developmental, physical, emotional disorders.
  8. 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:
  • Platelet-Rich Plasma-Fibrin Glue
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:
  • Platelet-Rich Plasma-Fibrin Glue

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

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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