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

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP gel

Drug

The PRP gel is applied on the ulcer twice per week

Saline dressing

Drug

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

Primary outcomes

Percent reduction in the ulcer size

Time frame: 20 weeks

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Sep 16, 2019
Registry last updated: Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed