Chronic UlcerPhase 1NCT03026855
Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
A Phase 1 study testing Autologous PRP Gel and PRP Injection in people with Chronic Ulcer, run by TotipotentRX Cell Therapy Pvt. Ltd. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Ulcer
- What is being tested?
- Autologous PRP Gel and PRP Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2014to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Demonstrate the Safety and Efficacy of Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
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.
Read the 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.
- Conditions
- Chronic Ulcer
- Being tested
- Autologous PRP Gel and PRP Injection
- Keywords
- Autologous PRP, Non-healing ulcer, Point-of-care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous PRP Gel and PRP InjectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous PRP Gel and PRP Injection | Experimental | 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. Receives: Biological: Autologous PRP Gel and PRP Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (4)
Time to Ulcer Healing
The average time taken for the ulcers to heal post PRP administration
Measured: 24 weeks
Reduction in Pain using VAS pain score
Improvement in Pain and discomfort following PRP therapy
Measured: 24 weeks
Changes in Quality of Life using the SF-36 Questionnaire
Improvement in Quality of Life of the patients following PRP therapy
Measured: 24 weeks
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startJun 2014
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- TotipotentRX Cell Therapy Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Suhail N Bukhari, MBBS, DNB, Principal investigator, Fortis Escorts Heart Institute and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026855
- Sponsor's protocol ID
- TPRX/PRP/NHU/141005
- Status last verified
- Jan 2017
- First submitted
- 4 Jan 2017
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28241824
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Demonstrate the Safety and Efficacy of Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
- ClinicalTrials.gov ID
- NCT03026855
- Acronym / sponsor ID
- TPRX/PRP/NHU/141005
- Conditions
- Chronic Ulcer
- Keywords
- Autologous PRP, Non-healing ulcer, Point-of-care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TotipotentRX Cell Therapy Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous PRP Gel and PRP Injection | Experimental | Biological: Autologous PRP Gel and PRP InjectionAutologous 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous PRP Gel and PRP InjectionAutologous 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. | Biological | Autologous PRP Gel and PRP Injection |
Primary outcome
Number of Wound/ Ulcers Healed
Time frame: 24 weeks
The number of wound/ ulcers healed will be assessed by visual inspection of reduction in wound size at 24 weeks post PRP therapy
4 secondary outcomes
Time to Ulcer Healing
Time frame: 24 weeks
Reduction in Pain using VAS pain score
Time frame: 24 weeks
Changes in Quality of Life using the SF-36 Questionnaire
Time frame: 24 weeks
Number of participants with treatment-related Adverse Events
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Derived from this study: PubMed 28241824Suthar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Suhail N Bukhari, MBBS, DNB principal investigator
Fortis Escorts Heart Institute and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous PRP Gel and PRP Injection in people with Chronic Ulcer, run by TotipotentRX Cell Therapy Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Wound/ Ulcers Healed (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03026855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.