A Randomized Trial on Platelet Rich Plasma Versus Saline... | NCT04090008

Studies
A Randomized Trial on Platelet Rich Plasma Versus Saline Dressing of Diabetic Foot Ulcers

NCT04090008

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Sep 16, 2019Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Diabetic Foot

Interventions

PRP gel
Saline dressing

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Feb 28, 2019Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

Sep 12, 2019

First Submission Date that Met QC Criteria

Sep 12, 2019

First Posted Date

Sep 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2019

Last Update Posted Date

Sep 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

New treatments for persistent DFU have emerged, among which are the bioengineered skin substitutes, extracellular matrix proteins products, matrix metalloproteinases modulators, and growth factor therapy. Platelet rich plasma (PRP) gel has been used for stimulating wound healing since the last decade of the 20th century. This randomized trial was conducted to assess the role of PRP in gel form as a treatment for clean non-healing diabetic foot ulcer in comparison to regular dressing with saline as a control.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRP gel	Active Comparator	PRP gel was applied to the ulcer twice per week after preparation and then the ulcer was covered with Vaseline gauze, few layers of sterile gauze and crepe bandage.	Drug: PRP gel
Saline dressing	Active Comparator	daily dressing of the ulcer with normal saline was done	Drug: Saline dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRP gel	Drug	The PRP gel is applied on the ulcer twice per week	PRP gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent reduction in the ulcer size	the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment	20 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients of both sexes aging below 70 years with non-infected chronic foot ulcer confined to one anatomical site. Chronicity was defined as non-healing ulcer for twelve or more weeks

Exclusion Criteria:

Patients with chronic limb ischemia.
Evidence of osteomyelitis in the affected foot
Exposed tendons, ligaments or bones at the base of ulcer
Patients who received radiotherapy or chemotherapy at time of study or within 3 months of its beginning.
Patients having low peripheral platelet count, low serum albumin level or low hemoglobin level

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sameh Emile, M.D.	Mansoura University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university hospital		Al Mansurah	Dakahlia Governorate	35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided