- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03935386
Standard Compression Therapy With/Without Application of Skin Allograft (Theraskin) for Venous Leg Ulcer Treatment
A Prospective Randomized Clinical Trial Comparing Multi-layer Bandage Compression Therapy With and Without a Biologically Active Human Skin Allograft for the Treatment of Chronic Venous Leg Ulcers
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Virginia
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Fairfax, Virginia, United States, 22042
- Inova Fairfax Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Inclusion Criteria: Subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization.
- Adult patients with venous leg ulcer(s) >1 month.
- A signed and dated informed consent form.
- Subject is able to comply with instructions and scheduled visits, not confined to bed,.
- Ulcer surface area >2cm2 but not >10cm in any dimension. The total not to exceed 18cm2
- ABPI >.8, Doppler ultrasound (biphasic or triphasic waveforms) consistent with adequate blood flow to the affected extremity, as determined by the Investigator.
- There is a minimum 2 cm margin between the qualifying study ulcer and any other ulcers on the specified leg, post-debridement) Note: If the subject has more than one qualifying VLU, the ulcer designated as the study ulcer will be at the discretion of the Investigator..
- Casual smoker not exceeding one pack per week -
Exclusion Criteria:Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
- Patients with ABPI <0.7.
- Clinical signs of infection requiring treatment. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after resolution of the infection).
- Taking systemic antibiotics, steroids or immunosuppressive drugs.
- History of poor compliance.
- Bedridden.
- Arterial or mixed etiology ulcers.
- Severe diabetic peripheral neuropathy.
- DVT in the last month.
- Participation in another clinical investigations in the month prior to recruitment.
- Poorly controlled hypertension.
- Coronary artery disease.
- Malignancy, respiratory or cardiac failure.
- Autoimmune disease.
- Liver (elevated enzymes)or kidney disease (elevated serum creatinine).
- Gangrene of the affected limb.
- Subject has suspected or confirmed signs/symptoms of gangrene or 5 wound infection on any part of the affected limb.
- Subject has a history of hypersensitivity to any of the material used in the compression dressing
- Subject has a history of hypersensitivity to any of the antibiotics or preservation agents listed in the TheraSkin Instructions for Use.
- Subject was previously treated under this clinical study protocol.
- Cytostatic therapy within the 12 months prior to randomization, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis).
- Subject has osteomyelitis (If the Investigator suspects the presence of osteomyelitis, the diagnosis must be confirmed by plain film Xray.)
- Subject has a history of bone cancer or metastatic disease on the affected limb, radiation therapy to the foot or has had chemotherapy within the 12 months prior to randomization.
- Subject has been treated with wound dressings that include growth factors, engineered tissues, or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, TheraSkin®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization.
Subject has a history of or any of the following current illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process:
- End-stage renal disease
- Immunosuppression
- Severe malnutrition
- Liver disease
- Aplastic anemia
- Scleroderma
- Acquired immune deficiency syndrome (AIDS) or HIV positive
- Connective tissue disorder
- Exacerbation of sickle cell anemia
- Subject is an employee or relative of any member of the Investigational site or the Sponsor.
- Subject is diabetic, HbA1c not to exceed 10% at time of enrollment.
- COPD -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Standard Compression
Standard multi-layer compression dressing with no graft or biologic material added
|
Compression therapy with a multi-layered compression dressing for the treatment of venous leg ulceration
|
ACTIVE_COMPARATOR: Standard Compression with application of human allograft
standard compression with application of a cryopreserved skin allograft (TheraSkin)
|
Application of a cryopreserved skin allograft (TheraSkin) beneath compression therapy with a multi-layered compression dressing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of wound healing, percentage of wounds that close, and change in wound size in subjects with venous leg ulcers treated with compression therapy with or without a cryopreserved skin allograft (TheraSkin)
Time Frame: Enrollment and data analysis is anticipated to require approximately 3 years.
|
Monitor changes in wound healing rate, percentage of wounds that close, and changes in wound size associated with two cohorts (multi-layered compression therapy vs. multi-layered compression therapy used in conjunction with a cryopreserved skin allograft.
|
Enrollment and data analysis is anticipated to require approximately 3 years.
|
Determine the number and severity of adverse events associated with the two treatment cohorts -- standardized multi-layered compression therapy and the same therapy with a cryopreserved skin allograft added.
Time Frame: Enrollment and data analysis is anticipated to require approximately 3 years.
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Measure the frequency and severity of adverse events associated with each treatment cohort.
|
Enrollment and data analysis is anticipated to require approximately 3 years.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip Garrett, DPM, Inova Hospital Wound Care Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soluble Inova
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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