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Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers

Primary Purpose

Venous Leg Ulcer

Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
PRP
Conventional therapy
Sponsored by
Jinnah Postgraduate Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 30-80 years of any gender presented with chronic venous leg ulcers Exclusion Criteria: Patients with history of peripheral arterial disease. Patients with history of acute venous thromboembolism. Patients with platelet count less than 150000. Patients with history of bleeding disorders. Patients with history of osteoporosis. Patients with history of peripheral neuropathy. Pregnant patients assessed by history and confirmed by dating scan. Patients with history of congestive cardiac failure, chronic liver disease, asthma, COPD, or stroke.

Sites / Locations

  • Jinnah Post graduate Medical centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Platelet-rich plasma

Conventional therapy

Arm Description

Under aseptic precautions 20 ml of venous blood was drawn and added to a test tube containing acid citrate dextrose in a ratio of 9:1 (blood: Acid citrate dextrose), centrifuged at 5000 rpm for 15 min to separate the red blood cells from the platelets and plasma. Then the supernatant and the buffy coat composed of platelets and plasma were collected and centrifuged again at 2000 rpm for 5-10 min. The bottom layer about 1.5 ml was taken and 10% calcium chloride was added (0.3 ml for 1 ml of PRP). Then the activated PRP was applied to the wound after proper surgical debridement and was dressed with a non-absorbent dressing (paraffin gauze). This process was repeated once weekly for 6 weeks.

These patients were treated conservatively by compression using graduated elastic stockings below the knee and dressing using saline and vaseline gauze weekly for 6 weeks.

Outcomes

Primary Outcome Measures

Complete healing
Complete healing is defined as 100% epithelialization
Length of ulcer
Length of ulcer in cm at the end of treatment
Width of ulcer
Width of ulcer in cm at the end of treatment

Secondary Outcome Measures

Full Information

First Posted
July 11, 2023
Last Updated
August 2, 2023
Sponsor
Jinnah Postgraduate Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05974982
Brief Title
Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers
Official Title
Comparison of the Outcome of Treatment With Autologous Platelet Rich Plasma Versus Conventional Therapy for Patients Presenting With Chronic Venous Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinnah Postgraduate Medical Centre

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
The use of PRP has dramatically increased in the fields of orthopedics, spine surgery, reconstructive plastic surgery, oral and maxillofacial surgery, and dermatological indications. Nonetheless, its use in the treatment of wounds is not as widespread as in other fields. In this experimental study, the treatment outcome of autologous PRP was assessed in comparison to conventional therapy among patients with chronic venous leg ulcers.
Detailed Description
Venous ulcers are the most common form of leg ulcers which have a significant impact on quality of life and work productivity. In addition, the costs associated with the long-term care of these chronic wounds are substantial. Conventional therapies such as dressings, surgical debridement, compression bandage, and even skin grafting cannot provide satisfactory healing since these treatments are not able to provide necessary growth factors that can modulate healing processes. Autologous platelet-rich plasma (PRP) is a safe, simple, affordable, and less expensive procedure in the treatment of chronic ulcers with reportedly good results. Since it is an autologous method, it is biocompatible and safe. Data from this would help in establishing it as a treatment of choice, thereby leading to a reduction in cost and benefiting the patient both financially and psychologically. PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e., five times more than normal platelet counts. PRP enhances wound healing by promoting the healing process by seven growth factors present in it. They are platelet-derived growth factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, and transforming growth factor. These growth factors are important in modulating mesenchymal cell recruitment, proliferation, and extra-cellular matrix synthesis during the healing process.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet-rich plasma
Arm Type
Experimental
Arm Description
Under aseptic precautions 20 ml of venous blood was drawn and added to a test tube containing acid citrate dextrose in a ratio of 9:1 (blood: Acid citrate dextrose), centrifuged at 5000 rpm for 15 min to separate the red blood cells from the platelets and plasma. Then the supernatant and the buffy coat composed of platelets and plasma were collected and centrifuged again at 2000 rpm for 5-10 min. The bottom layer about 1.5 ml was taken and 10% calcium chloride was added (0.3 ml for 1 ml of PRP). Then the activated PRP was applied to the wound after proper surgical debridement and was dressed with a non-absorbent dressing (paraffin gauze). This process was repeated once weekly for 6 weeks.
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
These patients were treated conservatively by compression using graduated elastic stockings below the knee and dressing using saline and vaseline gauze weekly for 6 weeks.
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Description
PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e., five times more than normal platelet counts. PRP enhances wound healing by promoting the healing process by seven growth factors present in it. They are platelet derived growth factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, transforming growth factor.
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
Conventional therapy
Primary Outcome Measure Information:
Title
Complete healing
Description
Complete healing is defined as 100% epithelialization
Time Frame
9 months
Title
Length of ulcer
Description
Length of ulcer in cm at the end of treatment
Time Frame
9 months
Title
Width of ulcer
Description
Width of ulcer in cm at the end of treatment
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 30-80 years of any gender presented with chronic venous leg ulcers Exclusion Criteria: Patients with history of peripheral arterial disease. Patients with history of acute venous thromboembolism. Patients with platelet count less than 150000. Patients with history of bleeding disorders. Patients with history of osteoporosis. Patients with history of peripheral neuropathy. Pregnant patients assessed by history and confirmed by dating scan. Patients with history of congestive cardiac failure, chronic liver disease, asthma, COPD, or stroke.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Ghafoor
Organizational Affiliation
Jinnah Post Graduate Medical Centre
Official's Role
Study Director
Facility Information:
Facility Name
Jinnah Post graduate Medical centre
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75510
Country
Pakistan

12. IPD Sharing Statement

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Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers

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