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

NCT04065594 | Completed DMC

• 1 other identifier: zagazig university 1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

ulcers; platelet rich plasma; ordinary dressing; non-healing

Outcome Measures

Primary Outcomes (1)

• change the ulcer size

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

  1.8 years

Study Arms (2)

PRP dressing

EXPERIMENTAL

Procedure: PRP dressing

conventional ordinary dressing

EXPERIMENTAL

Procedure: conventional ordinary dressing

Interventions

PRP dressing PROCEDURE

PRP dressing gel dressings for treatment of chronic ulcer

PRP dressing

conventional ordinary dressing PROCEDURE

conventional ordinary dressing for treatment of chronic ulcer

conventional ordinary dressing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Tamer Alsaied Alnaimy

Zagazig, Sharqia Province, 055, Egypt

Location

MeSH Terms

Conditions

Foot Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• tamer A Alnaimy, MD

  faculty of medicine Zagazig university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professour

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 22, 2019
• Study Start: June 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)