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

Ulcer Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065594
• Other study ID #: zagazig university 1
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: April 1, 2019

Study information

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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Skin Ulcer
• Foot Ulcer
• Non-Healing Ulcer of Skin
• Skin Ulcer
• Ulcer
• Ulcer Foot

Intervention

Procedure:
• PRP dressing
PRP dressing gel dressings for treatment of chronic ulcer
• conventional ordinary dressing
conventional ordinary dressing for treatment of chronic ulcer

Locations

Country	Name	City	State
Egypt	Tamer Alsaied Alnaimy	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change the ulcer size	healing of the ulcer is assessed using centimeter scale before each dressing	1.8 years