Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers

NCT03526913 | Completed DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic venous ulcers are considered a problem with a big morbidity impact on both the health facilities and patients, skin-grafting have shown not so perfect outcomes with such ulcers. In this study, the investigators compare combining autologous platelet rich plasma treatments with partial skin grafting in chronic ulcers, the results were compared to using only partial skin grafting, and among various types of chronic resistant ulcers.

Conditions

Chronic Venous Hypertension With Ulcer and Inflammation; Chronic Ulcer of Leg or Foot

Keywords

chronic leg ulcers, PRP; split-thickness skin graft; platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• Graft take

  percentage of graft take

  month

Study Arms (2)

PRP + STSG

EXPERIMENTAL

autologous PRP treatments every week prior to graft placement (STSG)

Procedure: PRP; Procedure: STSG

STSG Split Thickness Skin Graft

ACTIVE COMPARATOR

skin graft (STSG) (intervention)

Procedure: STSG

Interventions

PRP PROCEDURE

PRP: autologous platelet-rich plasma

Also known as: platelet rich plasma

PRP + STSG

STSG PROCEDURE

skin graft: Split Thickness Skin Grafting (STSG)

Also known as: split thickness skin graft

PRP + STSG; STSG Split Thickness Skin Graft

Eligibility Criteria

• Age: 12 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic ulcers for at least 6 months.
• Age ≧ 12 years.

You may not qualify if:

• Patients younger than 12 years of age.
• Patients with diabetes or other diseases affecting tissue healing.
• Patients with current ongoing pathologies in arterial or venous systems.
• Patients with malignant ulcers.
• Patients on corticosteroids or other drugs affecting tissue healing.
• Patients with unrealistic expectations.

Sponsors & Collaborators

• Noha Mohsen Omar: lead
• Menoufia University: collaborator

Related Publications (9)

• Fonder MA, Lazarus GS, Cowan DA, Aronson-Cook B, Kohli AR, Mamelak AJ. Treating the chronic wound: A practical approach to the care of nonhealing wounds and wound care dressings. J Am Acad Dermatol. 2008 Feb;58(2):185-206. doi: 10.1016/j.jaad.2007.08.048.

  PMID: 18222318 BACKGROUND

• Raffetto JD, Khalil RA. Matrix metalloproteinases and their inhibitors in vascular remodeling and vascular disease. Biochem Pharmacol. 2008 Jan 15;75(2):346-59. doi: 10.1016/j.bcp.2007.07.004. Epub 2007 Jul 7.

  PMID: 17678629 BACKGROUND

• Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. doi: 10.1152/physrev.2003.83.3.835.

  PMID: 12843410 BACKGROUND

• Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. 2004 Nov;114(6):1502-8. doi: 10.1097/01.prs.0000138251.07040.51.

  PMID: 15509939 BACKGROUND

• Pietramaggiori G, Scherer SS, Mathews JC, Gennaoui T, Lancerotto L, Ragno G, Valeri CR, Orgill DP. Quiescent platelets stimulate angiogenesis and diabetic wound repair. J Surg Res. 2010 May 1;160(1):169-77. doi: 10.1016/j.jss.2008.09.010. Epub 2008 Oct 10.

  PMID: 19482315 BACKGROUND

• Kakudo N, Minakata T, Mitsui T, Kushida S, Notodihardjo FZ, Kusumoto K. Proliferation-promoting effect of platelet-rich plasma on human adipose-derived stem cells and human dermal fibroblasts. Plast Reconstr Surg. 2008 Nov;122(5):1352-1360. doi: 10.1097/PRS.0b013e3181882046.

  PMID: 18971718 BACKGROUND

• Schultz GS, Sibbald RG, Falanga V, Ayello EA, Dowsett C, Harding K, Romanelli M, Stacey MC, Teot L, Vanscheidt W. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28. doi: 10.1046/j.1524-475x.11.s2.1.x.

  PMID: 12654015 BACKGROUND

• Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.

  PMID: 26339534 BACKGROUND

• Knighton DR, Ciresi K, Fiegel VD, Schumerth S, Butler E, Cerra F. Stimulation of repair in chronic, nonhealing, cutaneous ulcers using platelet-derived wound healing formula. Surg Gynecol Obstet. 1990 Jan;170(1):56-60.

  PMID: 2403699 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sherif M. Elkashty, PHD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MBBCH Cairo University

Model Details: Comparison of combined autologous PRP and skin grafting to skin grafting alone in chronic leg ulcers (comparing one ulcer to another in bilateral cases, or one half of ulcer to the other in big ulcers)

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 16, 2018
• Study Start: February 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: February 1, 2018
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: infinite
• Access Criteria: to all researchers