NCT02088268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

January 21, 2014

Last Update Submit

October 20, 2015

Conditions

Diabetic Ulcers on Both Feet

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

platelet-rich plasma

EXPERIMENTAL

wound healing

Other: wound healing

Interventions

wound healingOTHER

wound healing

platelet-rich plasma

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Interventions

Wound Healing

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Jeng Long-Bin

    organ transplantation center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

March 14, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

TW(1)