Treatment of PRP on Diabetes Wound

NCT ID: NCT02088268

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Diabetic Ulcers on Both Feet

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

platelet-rich plasma

wound healing

Group Type: EXPERIMENTAL

wound healing

Intervention Type: OTHER

wound healing

Interventions

wound healing

wound healing

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeng Long-Bin

Role: STUDY_CHAIR

organ transplantation center

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH102-REC1-110

Identifier Type: -

Identifier Source: org_study_id