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

NCT04315909 | Unknown Phase 2

• 1 other identifier: IR.MUMS.REC.1398.125
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcers; Diabetic Wound

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Healing rate of the ulcer

  Examination by a vascular surgery physician and documentation

  2 months

• 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.

  2 months

Secondary Outcomes (11)

• Serum ESR at baseline and after the intervention

  2 months

• Serum hs-CRP at baseline and after the intervention

  2 months

• FBS at baseline and after the intervention

  2 months

• HbA1c at baseline and after the intervention

  2 months

• Lipid Profile at baseline and after the intervention

  2 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Drug: PRP-Fibrin Glue; Dietary Supplement: Vitamin E and C

Control group

EXPERIMENTAL

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

Drug: PRP-Fibrin Glue; Other: Placebo

Interventions

PRP-Fibrin Glue DRUG

Platelet-Rich Plasma-Fibrin Glue

Also known as: Platelet-Rich Plasma-Fibrin Glue

Control group; Intervention group

Vitamin E and C DIETARY_SUPPLEMENT

Vitamin E and vitamin C

Intervention group

Placebo OTHER

Placebo

Control group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Alavi Hospital

Mashhad, Razavi Khorasan Province, 9137913316, Iran

RECRUITING

Related Publications (1)

• 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.

  PMID: 33646060 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Daryoush Hamidi Alamdari, Ph.D

  Mashhad University of Medical Sciences, Mashhad, Iran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daryoush Hamidi Alamdari, Ph.D

CONTACT

+98 51 3882 8574; hamidiad@mums.ac.ir

Amir Yarahmadi, Ph.D

CONTACT

+98 51 3882 8574; yarahmadiA961@mums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 20, 2020
• Study Start: August 28, 2019
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Access to data are allowed 6 months after the publication of results.
• Access Criteria: The investigator's data will be available for university staffs and academic institutions.

Locations

IR (1)