Clinical Study Of Affinity Versus SOC In The Management Of VLUs

Study Overview
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Brief Summary
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This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs. Affinity® will be used along with standard of care on venous leg ulcers (VLUs) of greater than 4 weeks which have not adequately responded to conventional ulcer therapy.

Detailed Description
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Two hundred (200) subjects with a chronic VLU ranging in size from 2cm2 and 80 cm2 will be randomized 1:1 to either Affinity® and SOC or SOC alone following the 28 day screening period. Following screening and randomization, subjects shall be seen weekly for up to 24 weeks. For subjects that heal prior to week 24, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure. Subjects that are randomized into the SOC group whose VLU has not healed by week 12 may be crossed over to receive Affinity® and followed for an additional 12-14 weeks.

Official Title
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A Prospective, Multicenter, Randomized, Controlled Clinical Study Of Affinity Versus SOC In The Management Of VLUs

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Other: Affinity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ulcers of venous origin, as clinically determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test). Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy Venous insufficiency ulcers between 2 cm2 and 80 cm2 Partial- or full-thickness VLU, including ulcers with tissue damage that extends through the epidermis and into the upper epidermis (papillary dermis), or into the deep dermis (reticular dermis) but not through muscle, tendon, capsule, or into bone. Subjects are between 18 and 85 years of age. IRB approved Informed Consent Form is signed before screening and treatment. Subject is expected to be available for 24 week follow-up Females of child-bearing potential must be practicing an acceptable means of birth control as determined by the investigator. Subjects with bilateral ulcers may be enrolled. Exclusion Criteria: Ankle Brachial Index (ABI) of <0.65 Venous insufficiency ulcers less than 2cm2 or greater than 80cm2 Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease Signs and symptoms of infection, cellulitis, osteomyelitis Necrotic or avascular ulcer beds Ulcer with exposed bone, tendon or fascia Subjects receiving hemodialysis or have uncontrolled diabetes Subjects who are currently receiving or have received at any time within one month prior to entry into the study, corticosteroids (>15 mg/day), immunosuppressive agents, radiation therapy, or chemotherapy. Anticipated use of the above agents will exclude subjects from entry into the study. Subjects enrolled in other wound drug investigational studies within the past three months, or device studies within the past 30 days. Subject is pregnant or breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Affinity plus SOC<br>Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM). Affinity is human allograft tissue that is regulated as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) as defined by FDA 21 CFR Part 1271. Affinity may be applied as a wound covering to partial- and full-thickness acute and chronic wounds | Other: Affinity<br>* Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM).<br>|
| No Intervention: Standard of Care (SOC)<br>Standard of Care (SOC) includes, but is not limited to, surgical debridement, aggressive infection management, offloading, and maintenance of appropriate cleansing at the time of each dressing change. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time that a wound achieves complete wound closure (CWC) | Duration (number of days) to achieve CWC from baseline to week 24 assessed between both groups | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time that a wound achieves complete wound closure (CWC) | Duration (number of days) to achieve CWC from baseline to week 12 assessed between both groups | 12 weeks | 
| Greater than 40% wound closure at week 4 from baseline | Proportion of subjects achieving ≥ 40% wound closure at Week 4 from baseline | 4 weeks | 
| VLU improvement by or on End of Study (EOS) from baseline | Defined by >60% reduction in area, or >60% reduction in depth, or >75% reduction in volume | 24 weeks | 
| Incidence of ulcer recurrence | Number of recurrent ulcers | 24 weeks | 
| Mean number of ulcer free days | Average number of ulcer free days | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VLU, Chronic Venous Leg Ulcer, Non-healing VLU