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

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Autologous Platelets Rich Plasma Treatment
Conventional Saline dressing
Sponsored by
Services Hospital, Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Services hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Autologous Platelets Rich Plasma

Conventional Saline dressing

Arm Description

In this group we will be managing diabetic wounds with platelet rich plasma treatment.

In this group we will be managing diabetic wounds with normal saline dressing.

Outcomes

Primary Outcome Measures

Wound Healing
complete healing of diabetic foot

Secondary Outcome Measures

Full Information

First Posted
July 11, 2018
Last Updated
October 21, 2018
Sponsor
Services Hospital, Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT03716141
Brief Title
Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer
Acronym
APRP
Official Title
Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Platelets Rich Plasma
Arm Type
Active Comparator
Arm Description
In this group we will be managing diabetic wounds with platelet rich plasma treatment.
Arm Title
Conventional Saline dressing
Arm Type
Active Comparator
Arm Description
In this group we will be managing diabetic wounds with normal saline dressing.
Intervention Type
Other
Intervention Name(s)
Autologous Platelets Rich Plasma Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Saline dressing
Intervention Description
saline dressing of diabetic wounds will be done
Primary Outcome Measure Information:
Title
Wound Healing
Description
complete healing of diabetic foot
Time Frame
8 to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmmood Ayyaz, mbbs, fcps
Organizational Affiliation
Services Hospital, Lahore
Official's Role
Study Director
Facility Information:
Facility Name
Services hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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