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NCT03716141 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

— APRP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03716141
Other study ID # s6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date August 30, 2018

Study information
Verified date October 2018
Source Services Hospital, Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 30, 2018
Est. primary completion date August 30, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• Conventional Saline dressing
saline dressing of diabetic wounds will be done

Locations
Country Name City State
Pakistan Services hospital Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wound Healing complete healing of diabetic foot 8 to 12 weeks
See also
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