Critical Limb IschemiaPhase 1/2NCT02941419
Treatment of PAD by Platelet Lysate for Therapeutic Angiogenesis
A Phase 1/2 study testing Platelet lysate in people with Critical Limb Ischemia, run by University of Jordan.
Trial summary
Induction of autologous angiogenesis in patients with critical limb ischemia using platelet lysate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Platelet lysate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2013to 9 Feb 2017
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Competent and willing to give informed consent, and to be available for all baseline treatment and follow up examinations required by the protocol.
- Gender: Male or female.
- Established Peripheral arterial disease, clinically and hemodynamically confirmed as per Rutherford 3, 4 and
- History of intermittent claudication for > eight weeks.
- Limited exercise due to moderate to severe claudication.
- Resting ankle brachial index (ABI) < 0.85, toe pressure ≤ 60 mm Hg, Toe brachial index (TBI) <0.6, or Trans-cutaneous oxygen pressure (TcPO2) ≤ 60 mmHg in the foot.
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- Not eligible for surgical or radiological revascularization.
- In case of diabetic patients, he/she should be on medication and fairly controlled (HbA1c <10%).
- Normal liver enzymes, serum creatinine < 1.4
- Normal platelet count.
- On regular medication for hypertension if any.
- No evidence of malignancy
- Low Questionnaire scores.
- Body mass index <30.
Who cannot join
- Women with child bearing potential, pregnant and lactating women.
- Rheumatoid Arthritis.
- History of neoplasm or malignancy in the past 10 years.
- Reported unstable cardiovascular disease, heart failure or symptomatic postural hypotension within 6 months before screening.
- Leg edema
- Inflammatory or progressive fibrotic disorder
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- Renal insufficiency or failure
- History of infectious disorder.
- Chronic inflammatory disease
- History of stroke or myocardial infarction ( < 3 months).
- Bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).
- Lab values for
- Hemoglobin <10 g/dl.
- Platelet count <100,000.
- Prothrombin time/ partial thromboplastin time (PT/PTT)> 3 seconds.
- Alanine aminotrasferase (ALT) and aspartatet aminotrasferase (AST) > 1.5x of the normal lab value.
- Creatinine ≥ 1.4
- Poorly controlled diabetes (HbA1c ≥10)
- Bilirubin > 1.5x of the normal lab value.
- Systemic autoimmune disease.
- Receiving immunosuppressant medications.
- Uncontrolled hypertension or hypotension.
- Abdominal aortic aneurism > 5 cm.
- Active or untreated Tuberculosis.
About this study
Official title: Safety and Efficacy of Platelet Lysate for Therapeutic Angiogenesis in Patients With Peripheral Arterial Disease
Induction of autologous angiogenesis in patients with critical limb ischemia using platelet lysate.
Read the detailed description
Ten male and female patients diagnosed with Peripheral artery disease (PAD), will be recruited. This diagnosis will be based on medical history, physical examinations, laboratory tests, and specific diagnostic tests. Patients qualified for this study, are patients with distal extremity ischemia indicated by claudication and rest pain present for a minimum of 4 weeks without evidence of improvement in response to conventional drug therapy; showed angiographic evidence of PAD in the affected limb; and were not candidates for surgical revascularization. Platelet lysate will be injected intramuscularly at different sites of the gastrocnemius muscle. The purpose of this study is to evaluate the safety and efficacy of platelet lysate injections into ischematic limbs of patients with PAD.
- Conditions
- Critical Limb Ischemia
- Being tested
- Platelet lysate
- Keywords
- Platelet lysate, Critical limb ischemia, Peripheral arterial disease
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet lysateBiological
Autologous intramuscular platelet lysate injection for patients with peripheral arterial disease
| Study group | Role | What they receive |
|---|---|---|
| Platelet lysate injection | Experimental | Injection of platelet lysate intramuscularly in the gastrocnemius muscle Receives: Biological: Platelet lysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the safety of platelet lysate injection
Patients will be assessed for any relevant adverse event resulting from the platelet lysate injection
Measured: 6 months
Secondary outcomes (1)
Assessment the efficacy of platelet lysate injection
Assessing the therapeutic benefit of all four platelet lysate injections by ankle brachial index (ABI).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start5 Mar 2013
- Primary completion15 Sep 2016
- Study completion9 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moath AlSmady, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941419
- Sponsor's protocol ID
- PADUJCTC
- Status last verified
- May 2017
- First submitted
- 19 Oct 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Platelet Lysate for Therapeutic Angiogenesis in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT02941419
- Acronym / sponsor ID
- PADUJCTC
- Conditions
- Critical Limb Ischemia
- Keywords
- Platelet lysate, Critical limb ischemia, Peripheral arterial disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 5 Mar 2013 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 9 Feb 2017 (actual)
- First posted
- 21 Oct 2016 (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.
Induction of autologous angiogenesis in patients with critical limb ischemia using platelet lysate.
Detailed description
Ten male and female patients diagnosed with Peripheral artery disease (PAD), will be recruited. This diagnosis will be based on medical history, physical examinations, laboratory tests, and specific diagnostic tests. Patients qualified for this study, are patients with distal extremity ischemia indicated by claudication and rest pain present for a minimum of 4 weeks without evidence of improvement in response to conventional drug therapy; showed angiographic evidence of PAD in the affected limb; and were not candidates for surgical revascularization. Platelet lysate will be injected intramuscularly at different sites of the gastrocnemius muscle. The purpose of this study is to evaluate the safety and efficacy of platelet lysate injections into ischematic limbs of patients with PAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platelet lysate injection | Experimental | Biological: Platelet lysateInjection of platelet lysate intramuscularly in the gastrocnemius muscle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Competent and willing to give informed consent, and to be available for all baseline treatment and follow up examinations required by the protocol.
- Gender: Male or female.
- Established Peripheral arterial disease, clinically and hemodynamically confirmed as per Rutherford 3, 4 and
- History of intermittent claudication for > eight weeks.
- Limited exercise due to moderate to severe claudication.
Key exclusion criteria (24 listed)
- Women with child bearing potential, pregnant and lactating women.
- Rheumatoid Arthritis.
- History of neoplasm or malignancy in the past 10 years.
- Reported unstable cardiovascular disease, heart failure or symptomatic postural hypotension within 6 months before screening.
- Leg edema
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 |
|---|---|---|
| Platelet lysateAutologous intramuscular platelet lysate injection for patients with peripheral arterial disease | Biological | Platelet lysate injection |
Primary outcome
Assessment the safety of platelet lysate injection
Time frame: 6 months
Patients will be assessed for any relevant adverse event resulting from the platelet lysate injection
1 secondary outcome
Assessment the efficacy of platelet lysate injection
Time frame: 6 months
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 4 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelet lysate in people with Critical Limb Ischemia, run by University of Jordan.
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 14 inclusion and 24 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Assessment the safety of platelet lysate injection (time frame: 6 months). 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 4 May 2017.