Status:
COMPLETED
Preliminary Testing of New Treatment for Chronic Leg Wounds
Lead Sponsor:
University of Pennsylvania
Conditions:
Venous Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 P...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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)
- 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.
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Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01858272
Start Date
September 1 2004
End Date
June 1 2009
Last Update
January 11 2017
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