Application of Platelet-Rich Fibrin on Diabetic Foot Wound

NCT05483777 | Unknown

• 1 other identifier: AIBU-HEM-EC-01
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was planned as a prospective case-control study to examine the effect of PRF application on wound healing in diabetic foot wound. The sample of the study will consist of patients with diabetic foot wounds, who met the inclusion criteria and agreed to participate in the study. It is planned to include 7 patients for the experimental group and 7 patients for the control group (14 patients in total). If the patient is in the experimental group, PRF will be applied to the diabetic foot wound, and in the control group, classic wound dressing (CWD) will be applied.

Conditions

Diabetic Foot

Keywords

Diabetic Foot; Platelet-Rich Fibrin; Wound Healing

Outcome Measures

Primary Outcomes (1)

• Wound Observation and Evaluation Form

  The length, width, depth, exudate, necrotic tissue, wound bed, skin around the wound, etc. aspects will be evaluated with this form.

  Healing on diabetic foot wounds at 12 weeks.

Study Arms (2)

PRF

EXPERIMENTAL

If the patient is in the experimental group, platelet rich fibrin will be applied to the diabetic foot wound.

Procedure: PRF

CWD

NO INTERVENTION

If the patient is in the control group, classic wound dressing will be applied to the diabetic foot wound.

Interventions

PRF PROCEDURE

Platelet-rich fibrin preparation and application technique will applied to the experimental group.

PRF

Eligibility Criteria

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

You may qualify if:

• st or 2nd degree diabetic foot wound according to Wagner classification
• Absence of infection in diabetic foot wound
• Being over 18 years old
• Willingness to participate in the research
• Absence of any allergic disease
• Absence of bleeding disorder
• Not receiving corticosteroid treatment
• Not using anticoagulant medication
• Not smoking
• Absence of circulatory disorders in the lower extremities
• HbA1c value below 12% (Mean blood glucose value 298 mg/dL) in the most recent examination

You may not qualify if:

• rd, 4th and 5th degree diabetic foot wound according to Wagner classification
• Presence of infection in diabetic foot wound
• Being under the age of 18
• Not being willing to participate in the research
• Presence of any allergic disease
• Having a bleeding disorder
• Being on corticosteroid treatment
• Using anticoagulant medication
• Smoking
• HbA1c value above 12% (average blood glucose value 298 mg/dL) in the most recent examination
• Having circulatory disorders in the lower extremities

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Related Publications (12)

• Lorig K, Ritter PL, Villa FJ, Armas J. Community-based peer-led diabetes self-management: a randomized trial. Diabetes Educ. 2009 Jul-Aug;35(4):641-51. doi: 10.1177/0145721709335006. Epub 2009 Apr 30.

  PMID: 19407333 BACKGROUND

• Mankan T, Erci B, Bahcecioglu Turan G, Akturk U. Turkish validity and reliability of the Diabetes Self-Efficacy Scale. Int J Nurs Sci. 2017 May 4;4(3):239-243. doi: 10.1016/j.ijnss.2017.05.001. eCollection 2017 Jul 10.

  PMID: 31406747 BACKGROUND

• Quarles BE. Educational methods increasing self-efficacy for the management of foot care in adults with diabetes and implementation of foot care behaviors, (Dissertation), Doctor of Philosophy in The College of Education at The University of Kentucky, Lexington, Kentucky; 2005

  BACKGROUND

• Kır Biçer E. Enç N. Diyabetik Ayak Bakımı Özetkililik Ölçeğinin geçerlik ve güvenirlik çalışması. Diyabet, Obezite ve Hipertansiyonda Hemşirelik Forumu. 2014;6(2):40-5.

  BACKGROUND

• Horne R, Hankins M. The Medication Adherence report Scale (MARS), 2001. (manuscript submitted for publication).

  BACKGROUND

• Şen, E. T., Berk, Ö. S., & Sindel, D. (2019). İlaç Uyumunu Bildirim Ölçeği'nin Türkçe Uyarlamasının Geçerlik ve Güvenirlik Çalışması. İstanbul Tıp Fakültesi Dergisi, 82(1), 52-61.

  BACKGROUND

• Pinto NR, Ubilla M, Zamora Y, Del Rio V, Dohan Ehrenfest DM, Quirynen M. Leucocyte- and platelet-rich fibrin (L-PRF) as a regenerative medicine strategy for the treatment of refractory leg ulcers: a prospective cohort study. Platelets. 2018 Jul;29(5):468-475. doi: 10.1080/09537104.2017.1327654. Epub 2017 Jul 20.

  PMID: 28727481 BACKGROUND

• Somani A, Rai R. Comparison of Efficacy of Autologous Platelet-rich Fibrin versus Saline Dressing in Chronic Venous Leg Ulcers: A Randomised Controlled Trial. J Cutan Aesthet Surg. 2017 Jan-Mar;10(1):8-12. doi: 10.4103/JCAS.JCAS_137_16.

  PMID: 28529414 BACKGROUND

• Ozer K, Colak O. Leucocyte- and platelet-rich fibrin as a rescue therapy for small-to-medium-sized complex wounds of the lower extremities. Burns Trauma. 2019 May 6;7:11. doi: 10.1186/s41038-019-0149-0. eCollection 2019.

  PMID: 31080838 BACKGROUND

• Londahl M, Tarnow L, Karlsmark T, Lundquist R, Nielsen AM, Michelsen M, Nilsson A, Zakrzewski M, Jorgensen B. Use of an autologous leucocyte and platelet-rich fibrin patch on hard-to-heal DFUs: a pilot study. J Wound Care. 2015 Apr;24(4):172-4, 176-8. doi: 10.12968/jowc.2015.24.4.172.

  PMID: 25853474 BACKGROUND

• Yuvasri G, Rai R. Comparison of Efficacy of Autologous Platelet-Rich Fibrin versus Unna's Paste Dressing in Chronic Venous Leg Ulcers: A Comparative Study. Indian Dermatol Online J. 2020 Jan 13;11(1):58-61. doi: 10.4103/idoj.IDOJ_119_19. eCollection 2020 Jan-Feb.

  PMID: 32055510 BACKGROUND

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.

  PMID: 16504849 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

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

Study Officials

• Arzu İLÇE, Ph.D

  Abant Izzet Baysal University

  STUDY DIRECTOR

• Muhammed Emin DEMİRKOL, M.D.

  Abant Izzet Baysal University

  STUDY DIRECTOR

• Ebru ÇELEBİ, MSc

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebru ÇELEBİ, MSc

CONTACT

+905354351520; ebruarabaci@ibu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: It is planned to include 7 patients for the experimental group and 7 patients for the control group (14 patients in total) in this research.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 2, 2022
• Study Start: February 15, 2023
• Primary Completion: October 30, 2023
• Study Completion: August 30, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share