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

Diabetic Foot Clinical Trial

Official title:

A Randomized Controlled Trial on Platelet Rich Plasma Gel Compared to Normal Saline Dressing of Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090008
• Other study ID #: Mansoura103
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: September 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 1, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

Intervention

Drug:
• PRP gel
The PRP gel is applied on the ulcer twice per week
• Saline dressing
Normal saline is used for dressing of the ulcer twice a week

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in the ulcer size	the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment	20 weeks