Back to results

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

Primary Purpose

Diabetic Foot Ulcers, Diabetic Wound

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

PRP-Fibrin Glue

Vitamin E and C

Placebo

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Platelet-Rich Plasma-Fibrin Glue, DFU, Vitamin E, Vitamin C, non-healing Diabetic Foot Ulcers

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Alavi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intervention group

Control group

Arm Description

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.

Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks.

Outcomes

Primary Outcome Measures

Healing rate of the ulcer

Examination by a vascular surgery physician and documentation

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.

Secondary Outcome Measures

Serum ESR at baseline and after the intervention

Erythrocyte Sedimentation Rate

Serum hs-CRP at baseline and after the intervention

high-sensitivity C-Reactive Protein

FBS at baseline and after the intervention

Fasting blood sugar

HbA1c at baseline and after the intervention

Glycated hemoglobin

Lipid Profile at baseline and after the intervention

Serum Triglyceride, Cholesterol, HDL, LDL, VLDL

Serum Urea at baseline and after the intervention

In a quantitative laboratory method

Serum Creatinine at baseline and after the intervention

In a quantitative laboratory method

Serum total bilirubin at baseline and after the intervention

In a quantitative laboratory method

Serum Uric acid at baseline and after the intervention

In a quantitative laboratory method

Serum Homocysteine at baseline and after the intervention

In a quantitative laboratory method

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.

Full Information

NCT ID

NCT04315909

First Posted

March 17, 2020

Last Updated

March 18, 2020

Sponsor

Mashhad University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04315909

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 28, 2019 (Actual)

Primary Completion Date

June 23, 2020 (Anticipated)

Study Completion Date

June 23, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mashhad University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcers, Diabetic Wound

Keywords

Platelet-Rich Plasma-Fibrin Glue, DFU, Vitamin E, Vitamin C, non-healing Diabetic Foot Ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

Experimental

Arm Description

Patients with non-healing Diabetic Foot Ulcers treated with PRP-Fibrin-Glue plus placebo for 8 weeks.

Intervention Type

Drug

Intervention Name(s)

PRP-Fibrin Glue

Other Intervention Name(s)

Platelet-Rich Plasma-Fibrin Glue

Intervention Description

Platelet-Rich Plasma-Fibrin Glue

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin E and C

Intervention Description

Vitamin E and vitamin C

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Healing rate of the ulcer

Description

Examination by a vascular surgery physician and documentation

Time Frame

2 months

Title

Wound Size

Description

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.

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Serum ESR at baseline and after the intervention

Description

Erythrocyte Sedimentation Rate

Time Frame

2 months

Title

Serum hs-CRP at baseline and after the intervention

Description

high-sensitivity C-Reactive Protein

Time Frame

2 months

Title

FBS at baseline and after the intervention

Description

Fasting blood sugar

Time Frame

2 months

Title

HbA1c at baseline and after the intervention

Description

Glycated hemoglobin

Time Frame

2 months

Title

Lipid Profile at baseline and after the intervention

Description

Serum Triglyceride, Cholesterol, HDL, LDL, VLDL

Time Frame

2 months

Title

Serum Urea at baseline and after the intervention

Description

In a quantitative laboratory method

Time Frame

2 months

Title

Serum Creatinine at baseline and after the intervention

Description

In a quantitative laboratory method

Time Frame

2 months

Title

Serum total bilirubin at baseline and after the intervention

Description

In a quantitative laboratory method

Time Frame

2 months

Title

Serum Uric acid at baseline and after the intervention

Description

In a quantitative laboratory method

Time Frame

2 months

Title

Serum Homocysteine at baseline and after the intervention

Description

In a quantitative laboratory method

Time Frame

2 months

Title

Pro-Oxidant Antioxidant Balance at baseline and after the intervention

Description

The PAB assay is a test to determine the oxidants and antioxidants simultaneously in one single test.

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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- 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daryoush Hamidi Alamdari, Ph.D

Phone

+98 51 3882 8574

hamidiad@mums.ac.ir

First Name & Middle Initial & Last Name or Official Title & Degree

Amir Yarahmadi, Ph.D

Phone

+98 51 3882 8574

yarahmadiA961@mums.ac.ir

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daryoush Hamidi Alamdari, Ph.D

Organizational Affiliation

Mashhad University of Medical Sciences, Mashhad, Iran

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alavi Hospital

City

Mashhad

State/Province

Razavi Khorasan

ZIP/Postal Code

9137913316

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohammad-Hadi Saeed Modaghegh, M.D

ModagheghMH@mums.ac.ir

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

33646060

Citation

Yarahmadi A, Saeed Modaghegh MH, Mostafavi-Pour Z, Azarpira N, Mousavian A, Bonakdaran S, Jarahi L, Samadi A, Peimani M, Hamidi Alamdari D. The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: a randomized, double-blind, parallel-group, clinical trial. Expert Opin Biol Ther. 2021 May;21(5):687-696. doi: 10.1080/14712598.2021.1897100. Epub 2021 Apr 13.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs