Back to resultsA Randomized Trial on Platelet Rich Plasma Versus Saline Dressing of Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PRP gel
Saline dressing
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot
Eligibility Criteria
Inclusion Criteria:
- adult patients of both sexes aging below 70 years with non-infected chronic foot ulcer confined to one anatomical site. Chronicity was defined as non-healing ulcer for twelve or more weeks
Exclusion Criteria:
- Patients with chronic limb ischemia.
- Evidence of osteomyelitis in the affected foot
- Exposed tendons, ligaments or bones at the base of ulcer
- Patients who received radiotherapy or chemotherapy at time of study or within 3 months of its beginning.
- Patients having low peripheral platelet count, low serum albumin level or low hemoglobin level
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PRP gel
Saline dressing
Arm Description
PRP gel was applied to the ulcer twice per week after preparation and then the ulcer was covered with Vaseline gauze, few layers of sterile gauze and crepe bandage.
daily dressing of the ulcer with normal saline was done
Outcomes
Primary Outcome Measures
Percent reduction in the ulcer size
the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT04090008
First Posted
September 12, 2019
Last Updated
September 12, 2019
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT04090008
Brief Title
A Randomized Trial on Platelet Rich Plasma Versus Saline Dressing of Diabetic Foot Ulcers
Official Title
A Randomized Controlled Trial on Platelet Rich Plasma Gel Compared to Normal Saline Dressing of Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
New treatments for persistent DFU have emerged, among which are the bioengineered skin substitutes, extracellular matrix proteins products, matrix metalloproteinases modulators, and growth factor therapy. Platelet rich plasma (PRP) gel has been used for stimulating wound healing since the last decade of the 20th century. This randomized trial was conducted to assess the role of PRP in gel form as a treatment for clean non-healing diabetic foot ulcer in comparison to regular dressing with saline as a control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP gel
Arm Type
Active Comparator
Arm Description
PRP gel was applied to the ulcer twice per week after preparation and then the ulcer was covered with Vaseline gauze, few layers of sterile gauze and crepe bandage.
Arm Title
Saline dressing
Arm Type
Active Comparator
Arm Description
daily dressing of the ulcer with normal saline was done
Intervention Type
Drug
Intervention Name(s)
PRP gel
Intervention Description
The PRP gel is applied on the ulcer twice per week
Intervention Type
Drug
Intervention Name(s)
Saline dressing
Intervention Description
Normal saline is used for dressing of the ulcer twice a week
Primary Outcome Measure Information:
Title
Percent reduction in the ulcer size
Description
the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients of both sexes aging below 70 years with non-infected chronic foot ulcer confined to one anatomical site. Chronicity was defined as non-healing ulcer for twelve or more weeks
Exclusion Criteria:
Patients with chronic limb ischemia.
Evidence of osteomyelitis in the affected foot
Exposed tendons, ligaments or bones at the base of ulcer
Patients who received radiotherapy or chemotherapy at time of study or within 3 months of its beginning.
Patients having low peripheral platelet count, low serum albumin level or low hemoglobin level
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Randomized Trial on Platelet Rich Plasma Versus Saline Dressing of Diabetic Foot Ulcers
We'll reach out to this number within 24 hrs