Venous Leg UlcerPhase 1NCT05974982
Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers
A Phase 1 study testing PRP and Conventional therapy in people with Venous Leg Ulcer, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- PRP and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2022to 25 May 2023
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 30-80 years of any gender presented with chronic venous leg ulcers
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Outcome of Treatment With Autologous Platelet Rich Plasma Versus Conventional Therapy for Patients Presenting With Chronic Venous Leg Ulcers
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.
Read the 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.
- Conditions
- Venous Leg Ulcer
- Being tested
- PRP, Conventional therapy
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
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.
Conventional therapyOther
Conventional therapy
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich plasma | Experimental | 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. Receives: Biological: PRP |
| Conventional therapy | Active comparator | 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. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete healing
Complete healing is defined as 100% epithelialization
Measured: 9 months
Length of ulcer
Length of ulcer in cm at the end of treatment
Measured: 9 months
Width of ulcer
Width of ulcer in cm at the end of treatment
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Sep 2022
- Primary completion25 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Faiza Inam Siddiqui, Jinnah Postgraduate Medical Centre
- Investigators
- Rabia Ghafoor, Study director, Jinnah Post Graduate Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974982
- Sponsor's protocol ID
- NO.F.2-81/2022-GENL/249/JPMC
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Outcome of Treatment With Autologous Platelet Rich Plasma Versus Conventional Therapy for Patients Presenting With Chronic Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT05974982
- Acronym / sponsor ID
- NO.F.2-81/2022-GENL/249/JPMC
- Conditions
- Venous Leg Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 3 Aug 2023 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich plasma | Experimental | Biological: PRPUnder 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. |
| Conventional therapy | Active comparator | Other: Conventional therapyThese patients were treated conservatively by compression using graduated elastic stockings below the knee and dressing using saline and vaseline gauze weekly for 6 weeks. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 30-80 years of any gender presented with chronic venous leg ulcers
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| PRPPRP 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. | Biological | Platelet-rich plasma |
| Conventional therapyConventional therapy | Other | Conventional therapy |
Primary outcome
Complete healing
Time frame: 9 months
Complete healing is defined as 100% epithelialization
Length of ulcer
Time frame: 9 months
Length of ulcer in cm at the end of treatment
Width of ulcer
Time frame: 9 months
Width of ulcer in cm at the end of treatment
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 3 Aug 2023.
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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.
Rabia Ghafoor study director
Jinnah Post Graduate Medical 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 PRP and Conventional therapy in people with Venous Leg Ulcer, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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 1 inclusion and 8 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 3 Aug 2023. 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 Pakistan. 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?
Complete healing (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2023.