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Treatment of PRP on Diabetes Wound (PRP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088268
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:
The purpose of this study is to focus on the effect of platelet-rich-plasma on diabtic ulcer foot, as adjuvant treatment along with the standard care of chronic diabetic, and evaluate the efficiency and the clinical application of PRP on serious wound healing.

Condition or disease Intervention/treatment Phase
Diabetic Ulcers on Both Feet Other: wound healing Not Applicable

Detailed Description:

Diabetes is a condition in which the body dose not effectively use sugar so that there is too much sugar in the blood. It is estimated that 15% of the diabetics suffer from diabetic food ulcers at some point. The healing process can be slow and easily to be infected with some pathogens so the patients are at risk in amputation. The wound healing process is a complex mechanism involves the interaction of molecular signals and different cell types. Platelets play important roles in wound healing. When injury occurs platelets are activated with thrombin and clot is formed. In addition to the function of hemostasis, activated platelets release many growth factors that trigger angiogenesis, extracellular matrix production and cytokine release, which is need for wound healing.

Platelet-rich plasma (PRP) is a portion of plasma fraction of autologous blood having a high concentration of thrombocytes. Thrombin induces the activation of PRP and results in the release of multiple growth factors, including platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), insulin-like growth factor (IGF), and transforming growth factor beta (TGF-β). PRP is known for the capacity to stimulate cell proliferation and differentiation. PRP can also interact with macrophage to improve tissue healing and regeneration, and exhibit potent activities against several kinds of pathogens.

Our study will focus on the advantage of PRP for aiding wound healing for diabetes. PRP from autologous blood can be mixed with thrombin in appropriate ratio and inject into the sites around the wound, as adjuvant treatment along with the standard care of chronic diabetic. The wound will be checked 1 to 2 times each week for the evaluation of PRP on clinical application.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment and Evaluation of Platelet-rich-plasma on Diabetes Wound Healing
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: platelet-rich plasma
wound healing
Other: wound healing
wound healing




Primary Outcome Measures :
  1. effect of PRP on diabete wound closure [ Time Frame: every 2 weeks, from the first date of PRP treatment and up to 12 weeks. ]

    The wound was checked twicw each month using a digital camera and ruler to trace the area of wound. Wound closure was determined as the percentage closed and calculated as:

    % Closed = [(Area on Day 0 - Open Area on Final Day)] x 100




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetic patient who suffers from sereious alcer feet.
  • age of 20-70 years old

Exclusion Criteria:

  • patient with systemic disorder
  • psycho
  • patient with coagulation abnormality
  • patient with inflammation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088268


Locations
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Taiwan
China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Chair: Jeng Long-Bin organ transplantation center
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02088268    
Other Study ID Numbers: CMUH102-REC1-110
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015