Venous UlcerPhase 1NCT01858272
Preliminary Testing of New Treatment for Chronic Leg Wounds
A Phase 1 study testing H5.020CMV.PDGF-b and limb compression bandage in people with Venous Ulcer, run by University of Pennsylvania.
Trial summary
The primary objectives of this study are to evaluate the efficacy, dosing, and safety of an intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer. The primary endpoint of this Phase I trial is the determination of the Maximum Tolerated Dose (MTD) for the intra-ulcer injection of H5.020CMV.PDGF-b. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- H5.020CMV.PDGF-b and limb compression bandage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Jun 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have an examination by study the investigator that is consistent with a venous leg ulcer (i.e., varicose veins, venous blush, wound in the gaiter area of the leg, dermatitis, lipodermatosclerosis).
- Subject must have received limb compression therapy for at least 6 weeks without improvement in wound size.
- The size of the study wound must be larger than 5 and smaller than 60 cm2 as measured by acetate trace and planimetry.
- By patient history, the study wound must be more than six months old.
- For subjects with more than one wound that meets requirements 2 and 3, only one wound will be randomly selected and treated with H5.020CMV.PDGF-b.
- By history, subject must be able to tolerate a limb compression bandage.
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- Ankle brachial index (ABI) greater than or equal to 0.85
- White blood cell count greater than or equal to 3500/mm3, platelets < 1,000,000/mm3 but greater than 100,000/mm3 and hemoglobin > 10.0 g%.
- Signed informed consent
- Subject age must be greater than or equal to 18 years of age. In reality, it would be very unlikely that anyone less than 45 years old will have a venous leg ulcer.
Who cannot join
- Subject with any active cancer other than a nonmelanomatous skin cancer. If cancer is in remission, subjects will be excluded unless the remission has extended for at least 10 years.
- Subjects with life expectancy of less than 6 months.
- Liver function tests (Alamine Amino Trandferase, ALT; angiotensin sensitivity test, AST; alkaline phosphatase ALK PHOS, and bilirubin) greater than 1.5x upper limit of normal for the reference lab.
- Sedimentation rate (ESR) at baseline of greater than 60.
- A Rheumatoid Factor at baseline that is greater than 30 IU/ml (Less than 30 IU/ml is considered negative and 30 to 80IU/ml is considered weakly positive by University of Pennsylvania Pathology Laboratories criteria in use as of March 2007).
- Anti Nuclear Antibody test of dilutional titer of greater than 1:160 (Less than 1:160 is considered negative by University of Pennsylvania Pathology Laboratories criteria in use as of March 2007)
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- Patients with inter-current organ damage, abnormal laboratory tests, or medical problems that in the opinion of the PI will jeopardize their ability to participate in this study or to heal their wound.
- Any subject with a recognized rheumatic disease (e.g., lupus, scleroderma, dermatomyositis, rheumatoid arthritis, polymyalgia, etc.) will be excluded from the study
- Pregnant or lactating females. A pregnancy test will be performed on each fertile premenopausal female prior to entry into the study. Treatment may not begin until the result of the pretreatment pregnancy test is ascertained.
- Any requirement for systemic corticosteroids or immunosuppressives, or history of corticosteroid or immunosuppressive use in the 4 weeks previous to study entry.
- Seropositive for hepatitis B or C surface antigen.
- Patient refusal to use or inability to successfully use a limb compression bandage changed weekly.
- Any concurrent medical illness that be exacerbated by H5.020CMV.PDGF-b administration.
- -
About this study
Official title: Phase I Trial to Evaluate the Safety of H5.020CMV.PDGF-b and Limb Compression Bandage for the Treatment of Venous Leg Ulcer (Trial A)
The primary objectives of this study are to evaluate the efficacy, dosing, and safety of an intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer. The primary endpoint of this Phase I trial is the determination of the Maximum Tolerated Dose (MTD) for the intra-ulcer injection of H5.020CMV.PDGF-b.
- Conditions
- Venous Ulcer
- Being tested
- H5.020CMV.PDGF-b and limb compression bandage
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5.020CMV.PDGF-b and limb compression bandageDrug
| Study group | Role | What they receive |
|---|---|---|
| H5.020CMV.PDGF-b and limb compression bandage | Experimental | This study will use a standard, three-six Phase I dose escalation scheme. Three subjects will be treated at the lowest dose. If zero of three experience dose limiting toxicity (DLT), three new subjects will be treated at the next higher dose. If one of three of the subjects at the lowest dose had experienced DLT, then three more for a total of six will receive the lowest dose. Of the six subjects who received the lowest dose, if only one of six experience DLT, then the dose will be escalated to the next higher dose. However, if more than one of six experiences DLT (i.e., any of the additional subjects), then the MTD will be declared and the next lower dose will be the recommended dose for future trials. Receives: Drug: H5.020CMV.PDGF-b and limb compression bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose.
The Maximum tolerated dose(MTD) for this trial will be defined as the highest dose at which zero or one of six subjects demonstrates Dose limiting toxicity (DLT).
Measured: 28 days after the subject receives the study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startSep 2004
- Primary completionAug 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J. Margolis, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858272
- Sponsor's protocol ID
- Limb compression
- Status last verified
- Jan 2017
- First submitted
- 8 May 2013
- Last updated
- 11 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial to Evaluate the Safety of H5.020CMV.PDGF-b and Limb Compression Bandage for the Treatment of Venous Leg Ulcer (Trial A)
- ClinicalTrials.gov ID
- NCT01858272
- Acronym / sponsor ID
- Limb compression
- Conditions
- Venous Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 May 2013 (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 primary objectives of this study are to evaluate the efficacy, dosing, and safety of an intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer. The primary endpoint of this Phase I trial is the determination of the Maximum Tolerated Dose (MTD) for the intra-ulcer injection of H5.020CMV.PDGF-b.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H5.020CMV.PDGF-b and limb compression bandage | Experimental | Drug: H5.020CMV.PDGF-b and limb compression bandageThis study will use a standard, three-six Phase I dose escalation scheme. Three subjects will be treated at the lowest dose. If zero of three experience dose limiting toxicity (DLT), three new subjects will be treated at the next higher dose. If one of three of the subjects at the lowest dose had experienced DLT, then three more for a total of six will receive the lowest dose. Of the six subjects who received the lowest dose, if only one of six experience DLT, then the dose will be escalated to the next higher dose. However, if more than one of six experiences DLT (i.e., any of the additional subjects), then the MTD will be declared and the next lower dose will be the recommended dose for future trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must have an examination by study the investigator that is consistent with a venous leg ulcer (i.e., varicose veins, venous blush, wound in the gaiter area of the leg, dermatitis, lipodermatosclerosis).
- Subject must have received limb compression therapy for at least 6 weeks without improvement in wound size.
- The size of the study wound must be larger than 5 and smaller than 60 cm2 as measured by acetate trace and planimetry.
- By patient history, the study wound must be more than six months old.
- For subjects with more than one wound that meets requirements 2 and 3, only one wound will be randomly selected and treated with H5.020CMV.PDGF-b.
Key exclusion criteria (14 listed)
- Subject with any active cancer other than a nonmelanomatous skin cancer. If cancer is in remission, subjects will be excluded unless the remission has extended for at least 10 years.
- Subjects with life expectancy of less than 6 months.
- Liver function tests (Alamine Amino Trandferase, ALT; angiotensin sensitivity test, AST; alkaline phosphatase ALK PHOS, and bilirubin) greater than 1.5x upper limit of normal for the reference lab.
- Sedimentation rate (ESR) at baseline of greater than 60.
- A Rheumatoid Factor at baseline that is greater than 30 IU/ml (Less than 30 IU/ml is considered negative and 30 to 80IU/ml is considered weakly positive by University of Pennsylvania Pathology Laboratories criteria in use as of March 2007).
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 |
|---|---|---|
| H5.020CMV.PDGF-b and limb compression bandage | Drug | H5.020CMV.PDGF-b and limb compression bandage |
Primary outcome
Maximum tolerated dose.
Time frame: 28 days after the subject receives the study drug.
The Maximum tolerated dose(MTD) for this trial will be defined as the highest dose at which zero or one of six subjects demonstrates Dose limiting toxicity (DLT).
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 11 Jan 2017.
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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.
David J. Margolis, MD, PhD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H5.020CMV.PDGF-b and limb compression bandage in people with Venous Ulcer, run by University of Pennsylvania.
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 10 inclusion and 14 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 11 Jan 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 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?
Maximum tolerated dose. (time frame: 28 days after the subject receives the study drug.). 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 11 Jan 2017.