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

Mansoura University24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot

Interventions

PRP gelDRUG

The PRP gel is applied on the ulcer twice per week

Saline dressingDRUG

Normal saline is used for dressing of the ulcer twice a week

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

Percent reduction in the ulcer size

the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment

Time frame: 20 weeks

Data from ClinicalTrials.gov

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