Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer (APRP)

October 21, 2018 updated by: Dr. SamiUllah, Services Hospital, Lahore
The aim of this study is to compare between the platelet rich plasma and normal saline dressing in the healing diabetic foot ulcers. It will be a randomized controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Services Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic foot wound less than 5cm in greatest diameter Non healing duration greater than 3 months Non infected Palpable distal pulses

Exclusion Criteria:

  • Infected wound Wound greater than 5 cm Patient having HBa1c greater than 8% Renal failure Wound with bone exposed or having osteomyelitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Autologous Platelets Rich Plasma
In this group we will be managing diabetic wounds with platelet rich plasma treatment.
Other: Autologous Platelets Rich Plasma Treatment
For PRP preparation 10 mL of the patient blood was collected. The blood was centrifuged at 2000 rpm for 5 min to obtain plasma. Then, this plasma was centrifuged at 3000 rpm for another 5 min to collect platelets. Platelets were diluted in 5 mL plasma to form PRP.
ACTIVE_COMPARATOR: Conventional Saline dressing
In this group we will be managing diabetic wounds with normal saline dressing.
Other: Conventional Saline dressing
saline dressing of diabetic wounds will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Healing
Time Frame: 8 to 12 weeks
complete healing of diabetic foot
8 to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

August 30, 2018

Study Completion (ACTUAL)

August 30, 2018

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

October 21, 2018

First Posted (ACTUAL)

October 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 21, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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