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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716141
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. SamiUllah, Services Hospital, Lahore

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Other: Autologous Platelets Rich Plasma Treatment Other: Conventional Saline dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Wound Healing [ Time Frame: 8 to 12 weeks ]
    complete healing of diabetic foot



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716141


Locations
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Pakistan
Services hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Services Hospital, Lahore
Investigators
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Study Director: Mahmmood Ayyaz, mbbs, fcps Services Hospital, Lahore

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Responsible Party: Dr. SamiUllah, principal investigator, Services Hospital, Lahore
ClinicalTrials.gov Identifier: NCT03716141    
Other Study ID Numbers: s6
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases