Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness
Primary Purpose
Ulcer Foot, Chronic Skin Ulcer, Non-Healing Ulcer of Skin
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PRP dressing
conventional ordinary dressing
Sponsored by
About this trial
This is an interventional treatment trial for Ulcer Foot focused on measuring ulcers, platelet rich plasma, ordinary dressing, non-healing
Eligibility Criteria
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.
Sites / Locations
- Tamer Alsaied Alnaimy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PRP dressing
conventional ordinary dressing
Arm Description
Outcomes
Primary Outcome Measures
change the ulcer size
healing of the ulcer is assessed using centimeter scale before each dressing
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04065594
Brief Title
Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness
Official Title
Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer Foot, Chronic Skin Ulcer, Non-Healing Ulcer of Skin
Keywords
ulcers, platelet rich plasma, ordinary dressing, non-healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP dressing
Arm Type
Experimental
Arm Title
conventional ordinary dressing
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
PRP dressing
Intervention Description
PRP dressing gel dressings for treatment of chronic ulcer
Intervention Type
Procedure
Intervention Name(s)
conventional ordinary dressing
Intervention Description
conventional ordinary dressing for treatment of chronic ulcer
Primary Outcome Measure Information:
Title
change the ulcer size
Description
healing of the ulcer is assessed using centimeter scale before each dressing
Time Frame
1.8 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tamer A Alnaimy, MD
Organizational Affiliation
faculty of medicine Zagazig university
Official's Role
Study Director
Facility Information:
Facility Name
Tamer Alsaied Alnaimy
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
055
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness
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