NCT03716141

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

July 11, 2018

Last Update Submit

October 21, 2018

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

  • Wound Healing

    complete healing of diabetic foot

    8 to 12 weeks

Study Arms (2)

Autologous Platelets Rich Plasma

ACTIVE COMPARATOR

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

Other: Autologous Platelets Rich Plasma Treatment

Conventional Saline dressing

ACTIVE COMPARATOR

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

Other: Conventional Saline dressing

Interventions

Autologous Platelets Rich Plasma TreatmentOTHER

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.

Autologous Platelets Rich Plasma
Conventional Saline dressingOTHER

saline dressing of diabetic wounds will be done

Conventional Saline dressing

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Mahmmood Ayyaz, mbbs, fcps

    Services Hospital, Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 11, 2018

First Posted

October 23, 2018

Study Start

January 1, 2018

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

PA(1)