NCT04065594

Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness

Completed NA Last updated 22 August 2019

What this trial tests

NA trial testing PRP dressing in Ulcer Foot in 44 participants. Completed in 1 April 2019.

Timeline

1 June 2017

Primary endpoint
1 January 2019

1 April 2019

Quick facts

Lead sponsor	Zagazig University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	44
Start date	1 June 2017
Primary completion	1 January 2019
Estimated completion	1 April 2019
Sites	1 location across Egypt

Drugs / interventions tested

• PRP dressing
• conventional ordinary dressing

Conditions studied

• Ulcer Foot — all drugs for Ulcer Foot →
• Chronic Skin Ulcer — all drugs for Chronic Skin Ulcer →
• Non-Healing Ulcer of Skin — all drugs for Non-Healing Ulcer of Skin →

Sponsor

Zagazig University

Who can join

Adults 18 to 80, any sex, with Ulcer Foot or Chronic Skin Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background

Chronic non-healing ulcer is a common problem met in clinical practice and represents a burden to the patients. Chronic ulcer lacks growth factors (GFs) to promote the healing process and is frequently followed by superadded infections. Ordinary technique such as wound debridement and regular dressings cannot provide adequate results as these techniques cannot provide the necessary GFs. Platelet-rich plasma (PRP) helps wound healing by releasing various types of GFs.

The aim: to evaluate and compare the efficacy of PRP dressing versus traditional dressings in the treatment of chronic non-healing leg and foot ulcers of different etiology as regard cost of overall treatment and effectiveness (reduction of the size of the ulcer and safety of the technique).

Methods

This prospective study was performed on inpatients and outpatients in general surgery department, Zagazig university hospital from June 2017 to January 2019. Patients were divided randomly into two groups: group A received PRP dressing (N=22, 50%) and group B received conventional ordinary dressing (N=22, 50%).The mean follow-up period was 3 months after the last dressing. Patients treated with PRP at once-weekly interval for a maximum of 12 dressings while patients with ordinary dressings may need one dressing every other day for a maximum of 12 weeks. The reduction in the size of the ulcers (area and volume) in both groups was assessed using centimeter scale and Digital photographs before and after each session and during follow up period.

Keywords: Platelet-rich plasma, ulcers, non-healing, ordinary dressing.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.