Treatment of PRP on Diabetes Wound

Diabetic Ulcers on Both Feet Clinical Trial

— PRP  

Official title:

Treatment and Evaluation of Platelet-rich-plasma on Diabetes Wound Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088268
• Other study ID #: CMUH102-REC1-110
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: October 20, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Ulcers on Both Feet

Intervention

Other:
• wound healing
wound healing

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of PRP on diabete wound closure	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	every 2 weeks, from the first date of PRP treatment and up to 12 weeks.	No