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Completed

NCT Number: NCT04065594

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tamer Alsaied Alnaimy

Zagazig, Sharqia Province, 055, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-80 years old,
  • males and non-pregnant females,
  • hemoglobin (> 10 gm. /dL),
  • post-prandial blood sugar ≤ 140 mg% if diabetic,
  • Wounds free of infection (sterile swab) or necrosis.

Exclusion criteria

  • malignant ulcer(by biopsy),
  • pus discharge/slough,
  • ulcer with exposed tendons/ligaments/bone,
  • ischemic ulcer (by duplex U/S),
  • non-compliant patients ,
  • radiation near to the site of ulcer,
  • osteomyelitis of underlying bone (x-ray-bone scan) ,
  • steroids therapy ,
  • thrombocytopenia(< 150,000/dl)
  • patients unfit or refuse blood donation from himself or from others.

Treatment and study plan

PRP dressing

Procedure

PRP dressing gel dressings for treatment of chronic ulcer

conventional ordinary dressing

Procedure

conventional ordinary dressing for treatment of chronic ulcer

Primary outcomes

  1. change the ulcer size

    Time frame: 1.8 years

    healing of the ulcer is assessed using centimeter scale before each dressing

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2019
Registry last updated
Aug 22, 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.

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