Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
Primary Purpose
Chronic Ulcer
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Autologous PRP Gel and PRP Injection
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Ulcer focused on measuring Autologous PRP, Non-healing ulcer, Point-of-care
Eligibility Criteria
Inclusion Criteria:
- Male or Female 18 to 85 years of age
- Chronic or Non-healing ulcer of any etiology (venous, pressure, arterial or diabetic foot ulcer) which is at least 4 weeks old
- Index foot ulcer located on the plantar, medial or lateral aspect of the foot (including all toe surfaces)
- Wound area (length x width) measurement must be between 0.5 cm^2 and 10 cm^2, inclusive
- If more than one non-healing ulcers is present, the largest wound will be selected
- Index ulcer must be clinically non-infected
- Full-thickness ulcer without exposure of bone, muscle, ligament or tendon
- Written informed consent must be obtained from either the patient or the patients legally acceptable representative prior to enrollment
Exclusion Criteria:
- Patients with known sensitivity to components of the PRP kit (calcium chloride, thrombin, acid citrate dextrose solution A (ACD-A))
- Smokers and individuals with systemic disease or history of anticoagulant, immuno-suppressive or antibiotic therapy in the last 3 months
- Platelet count < 105 x 10^3/ uL (according to CBC)
- Hemoglobin level < 10 g/dL (according to CBC)
- Wound is clinically infected
- Presence of platelet dysfunction syndrome or critical thrombocytopenia
- Bleeding disorders, collagen vascular disease or severe cardiovascular disorder
- Any malignancy other than non-melanoma skin cancer
- Patient is currently receiving or has received radiation or chemotherapy within 3 months prior to treatment
- If female, patient is pregnant, nursing or plans to become pregnant during the duration of the study
- Subject has inadequate venous access for blood draw required for PRP preparation
- Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
- Subject is on dialysis or has uncontrolled sugar levels
Sites / Locations
- Fortis Escorts Heart Institute and Research Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous PRP Gel and PRP Injection
Arm Description
Autologous PRP will be prepared using an advanced rapid point-of-care technology, the Res-Q™ 60 PRP system at the patient's bed side. The Activator solution for PRP gel will be prepared by combining human thrombin (500 IU/ml) with 1% Calcium Chloride.
Outcomes
Primary Outcome Measures
Number of Wound/ Ulcers Healed
The number of wound/ ulcers healed will be assessed by visual inspection of reduction in wound size at 24 weeks post PRP therapy
Secondary Outcome Measures
Time to Ulcer Healing
The average time taken for the ulcers to heal post PRP administration
Reduction in Pain using VAS pain score
Improvement in Pain and discomfort following PRP therapy
Changes in Quality of Life using the SF-36 Questionnaire
Improvement in Quality of Life of the patients following PRP therapy
Number of participants with treatment-related Adverse Events
Safety of the treatment will be assessed by measuring the number of treatment related adverse events and adverse reactions during the follow-up period
Full Information
NCT ID
NCT03026855
First Posted
January 4, 2017
Last Updated
January 17, 2017
Sponsor
TotipotentRX Cell Therapy Pvt. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03026855
Brief Title
Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
Official Title
To Demonstrate the Safety and Efficacy of Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TotipotentRX Cell Therapy Pvt. Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of autologous PRP injection in combination with topical application of PRP gel in treating chronic or non-healing ulcers on lower extremity using a rapid, intra-operative, point-of-care technology at the patient's bedside.
Detailed Description
Platelet Rich Plasma (PRP) therapy is an innovative treatment that uses body's own cells to relieve pain and promote accelerated healing of Non-healing Foot Ulcer /Wound. The body's response to any tissue injury is to deliver platelets, which play an instrumental role in the normal healing process by secreting growth factors and attracting stem cells-critical components of the healing cascade.
Any wound or ulcer on skin that has been present for 4-5 weeks duration, without healing is called a non-healing ulcer. Non-healing ulcers include venous, arterial, diabetic, pressure and traumatic ulcers. Cellular therapies using Autologous Platelet Rich Plasma provides new options for wound healing. The efficacy of the treatment has been proven in surgical applications, in the treatment of severe burns and in transplantation of cells and tissues.
Local application of a solution of plasma enriched in platelets derived from the patient's blood intends to trigger the healing process in non-responsive chronic wound, increase the wound repair rate and reduce pain. PRP is a good option for non-healing wounds because it utilizes the body's natural healing processes to jump-start wound healing. Plasma which contains very valuable growth factors is separated from other blood components utilizing a point of care technology based on density gradient centrifugation. The platelet rich plasma is harvested and then activated by a mixture of human thrombin and calcium chloride for initiating the healing cascade followed by PRP injection directly into the ulcer/wound periphery or spread over a wound in the form of a PRP gel.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ulcer
Keywords
Autologous PRP, Non-healing ulcer, Point-of-care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous PRP Gel and PRP Injection
Arm Type
Experimental
Arm Description
Autologous PRP will be prepared using an advanced rapid point-of-care technology, the Res-Q™ 60 PRP system at the patient's bed side. The Activator solution for PRP gel will be prepared by combining human thrombin (500 IU/ml) with 1% Calcium Chloride.
Intervention Type
Biological
Intervention Name(s)
Autologous PRP Gel and PRP Injection
Intervention Description
Autologous PRP prepared using the Res-Q™ 60 PRP system from patient's whole blood, will be injected subcutaneously around the periphery of the wound/ulcer.
Based on the wound size and area, autologous platelet gel obtained by spraying simultaneously equal volumes of PRP and activator solution (thrombin with calcium chloride) will be applied topically over the ulcer or wound.
Single dose of PRP injections and application of PRP gel will be administered, only on the day of treatment.
Primary Outcome Measure Information:
Title
Number of Wound/ Ulcers Healed
Description
The number of wound/ ulcers healed will be assessed by visual inspection of reduction in wound size at 24 weeks post PRP therapy
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Time to Ulcer Healing
Description
The average time taken for the ulcers to heal post PRP administration
Time Frame
24 weeks
Title
Reduction in Pain using VAS pain score
Description
Improvement in Pain and discomfort following PRP therapy
Time Frame
24 weeks
Title
Changes in Quality of Life using the SF-36 Questionnaire
Description
Improvement in Quality of Life of the patients following PRP therapy
Time Frame
24 weeks
Title
Number of participants with treatment-related Adverse Events
Description
Safety of the treatment will be assessed by measuring the number of treatment related adverse events and adverse reactions during the follow-up period
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female 18 to 85 years of age
Chronic or Non-healing ulcer of any etiology (venous, pressure, arterial or diabetic foot ulcer) which is at least 4 weeks old
Index foot ulcer located on the plantar, medial or lateral aspect of the foot (including all toe surfaces)
Wound area (length x width) measurement must be between 0.5 cm^2 and 10 cm^2, inclusive
If more than one non-healing ulcers is present, the largest wound will be selected
Index ulcer must be clinically non-infected
Full-thickness ulcer without exposure of bone, muscle, ligament or tendon
Written informed consent must be obtained from either the patient or the patients legally acceptable representative prior to enrollment
Exclusion Criteria:
Patients with known sensitivity to components of the PRP kit (calcium chloride, thrombin, acid citrate dextrose solution A (ACD-A))
Smokers and individuals with systemic disease or history of anticoagulant, immuno-suppressive or antibiotic therapy in the last 3 months
Platelet count < 105 x 10^3/ uL (according to CBC)
Hemoglobin level < 10 g/dL (according to CBC)
Wound is clinically infected
Presence of platelet dysfunction syndrome or critical thrombocytopenia
Bleeding disorders, collagen vascular disease or severe cardiovascular disorder
Any malignancy other than non-melanoma skin cancer
Patient is currently receiving or has received radiation or chemotherapy within 3 months prior to treatment
If female, patient is pregnant, nursing or plans to become pregnant during the duration of the study
Subject has inadequate venous access for blood draw required for PRP preparation
Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
Subject is on dialysis or has uncontrolled sugar levels
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Suhail N Bukhari, MBBS, DNB
Organizational Affiliation
Fortis Escorts Heart Institute and Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fortis Escorts Heart Institute and Research Centre
City
Delhi
ZIP/Postal Code
110025
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28241824
Citation
Suthar M, Gupta S, Bukhari S, Ponemone V. Treatment of chronic non-healing ulcers using autologous platelet rich plasma: a case series. J Biomed Sci. 2017 Feb 27;24(1):16. doi: 10.1186/s12929-017-0324-1.
Results Reference
derived
Learn more about this trial
Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
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